NDC | 0498-0021-40, 0498-0031-40, 0498-0100-02, 0498-0143-04, 0498-0501-00, 0498-0733-00, 0498-0750-36, 0498-0800-35, 0498-2422-01, 0498-3334-00, 0498-4248-01 |
Set ID | 85e3931e-a2fb-0f2f-e053-2a91aa0a27ec |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, INC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist, Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic |
Product Number | |
Application Number |
- Eyewash Active ingredient
- Eyewash Purpose
- Eyewash Uses
- Eyewash Warnings
For external use only Obtain immediate medical treatment for all open wounds in or near eyes. To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.
Do not use
- if solution changes color or becomes cloudy
- if you have open wounds in or near the eyes, get medical help right away.
Stop use and ask a doctor if
- you experience eye pain
- changes in vision
- continued redness or irritation of the eye
- condition worsens or persists
Keep out of reach of children
- If swallowed, get medical help or contact a Poison Control Center right away.
- Eyewash Directions
- remove contacts before using
- twist top to remove
- flush the affected area as needed
- control rate of flow by pressure on the bottle
- if necessary, continue flushing with emergency eyewash or shower
- Eyewash Inactive ingredients
- Eyewash Questions
- Ammonia Active ingredient
- Ammonia Purpose
- Ammonia Uses
- Ammonia Warnings
For external use only
Keep out of reach of children
- If swallowed get medical help or contact a Poison Control Center right away.
- Ammonia Directions
- hold inhalant away from face and crush ampoule between thumb and forefinger at position indicated on sleeve.
- hold near nostrils for inhalation of volatile vapor
- Ammonia Other information
- Ammonia Inactive ingredient
- Ammonia Questions or Comments?
- Water Soluble 1st Aid Spray Active ingredient
- Water Soluble 1st Aid Spray Purpose
- Water Soluble 1st Aid Spray Uses
for temporary relief of pain and itching and helps protect against infection in
- minor cuts and scrapes
- insect bites
- minor skin irritations
- Water Soluble 1st Aid Spray Warnings
For external use only
Flammable
- keep away from fire or flame
- contents under pressure
- do not puncture or incinerate container
- do not expose to temperature above 120 0 F
Do not use
- in the eyes or other mucous membranes
- in cases of serious burns
- in case of deep orpuncture wounds
- for a prolonged period of time
- on large portion of the body
Stop use and ask a doctor if- condition worsens or symptoms persist for more than 7 days
- condition clears up and occurs again within a few days
- redness, swelling, or irritation occurs
Keep out of reach of children
- If swallowed, get medical help or contact a Poison Control Center right away
- Water Soluble 1st Aid Spray Directions
- clean the affected area
- shake can well before using
- hold 4 - 6 inches from surface and spray area until wet
- may be covered with a sterile bandage. If bandaged, let dry first
- for adult institutional use only
- not intended for use on children
- Water Soluble 1st Aid Spray Other information
- avoid inhaling
- use only as directed
- intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal
- Water Soluble 1st Aid Spray Inactive ingredients
- Burn Relief Water Soluble Active ingredients
- Burn Relief Water Soluble Purpose
- Burn Relief Water Soluble Uses
for the temporary relief of pain and itching and helps protect against infection in:
- minor cuts and scrapes
- burns
- sunburn
- insect bites
- minor skin irritations
- Burn Relief Water Soluble Warnings
For external use only
Flammable keep away from fire or flame
- contents under pressure
- do not puncture or incinerate container
- do not expose to temperatures above 120 0 F
Do not use
- in or near the eyes or other mucous membranes
- in case of serious burns
- in case of deep or puncture wounds
- for prolonged period of time
- on large portion of the body
Stop use and ask a doctor if
- condition worsens or symptoms persist for more than 7 days
- condition clears up and recurs within a few days
- redness, swelling, or irritation occurs
Keep out of the reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
- Burn Relief Water Soluble Directions
- clean the affected area
- shake can well before using
- hold 4 - 6 inches from surface and spray area until wet
- may be covered with a sterile bandage, if bandaged let dry first
- for adult institutional use only
- not intended for use on children
- Burn Relief Water Soluble Other information
- avoid inhaling
- use only as directed
- intentional misuse by deliberately concentrating or inhaling the contents may be harmful or fatal
- Burn Relief Water Soluble Inactive ingredients
- Triple Active ingredients
Bacitracin zinc 400 units
Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)
Polymyxin B sulfate 5000 units
Close - Triple Purpose
- Triple Uses
- Triple Warnings
For external use only
Allergy alert do not use if you are allergic to any of the ingredients
Stop use and ask a doctor if- the condition persists or gets worse
- a rash or other allergic reaction develops
- you need to use longer than 1 week
Keep out of the reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
- Triple Directions
- clean the affected area
- apply a small amount of the product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
- may be covered with a sterile bandage
- Triple Other information
- store at 15 0 to 25 0 C (59 0 to 77 0 F)
- tamper evident sealed packets
- do not use if packet is torn or opened
- Triple Inactive ingredient
- Alcohol Active ingredient
- Alcohol Purpose
- Alcohol Uses
- Alcohol Warnings
For external use only
Flammable, keep away from fire or flame.
Keep out of reach of children
- If swallowed, get medical help or contact a Poison Control Center right away.
- Alcohol Directions
- clean the affected area
- apply wipe to affected area 1 to 3 times daily
- may be covered with a sterile bandage
- discard wipe after single use
- Alcohol Other information
- Alcohol Inactive ingredient
- Miralac Active ingredient (in each chewable tablet)
- Miralac Purpose
- Miralac Uses
for the relief of
- acid indigestion
- heartburn
- sour stomach
- upset stomach associated with these symptoms
- Warnings
Ask a doctor before use if you have
- kidney stones
- calcium-restricted diet
Ask a doctor before use if you are
- presently taking a prescription drug. Antacids may interfere with certain prescription drugs
When using this product
- do not take more than 12 tablets in a 24- hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.
Keep out of the reach of children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
- Miralac Directions
- Miralac Other information
- each tablet contains: calcium 170 mg
- sucrose free
- lactose free
- store at room temperature
- TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN
- Miralac Inactive ingredients
- Miralac Questions or comments?
- BZK Active ingredient
- BZK Purpose
- BZK Uses
- BZK Warnings
For external use only
Do not use
- in the eyes or over large areas of the body
- on mucous membranes
- on irritated skin
- in case of deep puncture wounds, animal bites or serious burns, consult a doctor
- longer than 1 week unless directed by a doctor
Stop use and ask a doctor if
- if irritation, redness or other symptoms develop
- the condition persists or gets worse
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away - BZK Directions
- BZK Other information
- BZK Inactiave ingredient
- BzK Questions
- Aypanal Active ingredient
- Aypanal Purpose
- Aypanal Uses
- temporarily relieves minor aches and pains due to the common cold and headache
- temporarily reduces fever
- Aypanal Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg in 24 hours, which is the maximum daily amount.
- with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If skin reaction occurs, stop use and seek medical help right away
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription).
- If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
Keep out of reach of children.
Keep out of reach of children.
Overdose warning: In case ofl overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Aypanal Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years of age and over: Take 2 tablets with water every 6 hours while symptoms last.
- do not take any more than 8 tablets in 24 hours.
- children under 12: consult a doctor
- Aypanal Other information
- store at room temperature 15 0 -30 0 C (59 0 -86 0 F)
- TAMPER EVIDENT- DO NOT USE IF OPEN OR TORN
- Aypanal Inactive igredients
- Aypanal Questions or Comments
- Hydrocortisone Active ingredient (in each gram)
- Hyrdocortisone Purpose
- Hydrocortisone Uses
- Hydrocortisone Warnings
For external use only
When using the product
- avoid contact with eyes
- do not begin use of any other hydrocortisone product unless you have consulted a doctor
- do not use for the treatment of diaper rash
Stop use and ask a doctor if
- condition worsens
- condition persists for more than 7 days
- condition clears up and recurs within a few days
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away
- Hydrocortisone Directions
- adults and children 2 years and older:
- clean the affected area
- apply to the area not more than 3 to 4 times daily
- children under 2 years of age: consult a doctor
- Hydrocortisone Other information
- Hydrocortisone Inactive ingredients
cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine
Close - Hydrocortisone Questions or Comments?
- Sting Relief Active ingredient (in each wipe)
- Sting Relief Purpose
- Sting Relief Uses
- prevent infection in minor scrapes, and temporary relief of itching of insect bites
Stop use and ask a doctor
- if conditions worsen or persist for more than 7 days or clear up and occur again within a few days
- Sting Relief Warnings
For external use only
Flammable, keep away from open fire or flame
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- Sting Relief Directions
- adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily.
- children under 2 years of age: consult a doctor.
- Sting Relief Inactive ingredients
- Questions or Comments?
- Pain Stopper Active ingredient (in each tablet)
Acetaminophen 110mg
Aspirin 162mg (NSAID)*
Caffeine 32.4mg
Salicylamide 152mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Close - Pain Stopper Purpose
- Pain Stopper Uses
for the temporary relief of minor aches and pains due to:
• common cold
• headache
• muscular aches
• premenstrual and menstrual cramps
Close - Pain Stopper Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 tablets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
Stop using and ask a doctor if
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pin that does not get better
- if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product.
If pregnant or breast-feeding
- ask a healthcare professional before use.
It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during pregnancy.
KEEP OUT OF REACH OF CHILDREN.
Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
- Pain Stopper Directions
- adults and children 12 years of age and over, take 2 tablets every 4 hours while symptoms persist
- do not take more than 12 tablets in 24 hours
- children under 12 years: consult a doctor
- Pain Stopper Other information
- store at a controlled room temperature 15 0 -30 0 C (59 0 -86 0 F)
- TAMPER EVIDENT-DO NOT USE IF OPEN OR TORN
- Pain Stopper Inactive ingredients
FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch, stearic acid,
Close - Pain Stopper Questions or Comments?
- Sinus Decongestant Active ingredient (in each tablet)
- Sinus Decongestant Purpose
- Sinus Decongestant Uses
- temporarily relieves these symptoms associated with hayfever and other upper respiratory allergies
- headache
- sinus congestion and pressure
- nasal congestion
- minor aches and pains
- helps decongest sinus openings and passages
- Sinus Decongestant Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur
- if you take more than 4,00 mg acetaminophen in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If skin reaction occurs, stop use and seek medical attention right away.
Do not use
- with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibiter (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before use.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- liver disease
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occur
- pain or nasl congestion get worse or last more than 7 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
Keep out of the reach of children.
Overdose warning: In case of accidental overdose, getmedical help or contact a Poison Control Center right away. Promt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
- Sinus Decongestant Directions
do not take more than directed (see overdose warning)
Adults and children 12 years of age and older: take 2 tablets every 4-6 hours while symptoms persist
- do not exceed 8 tablets in 24 hours unless directed by a doctor
Children under 12 years: consult a doctor
Close - Sinus Decongestant Other information
- store at room temperature 15-30C (59-86F)
- avoid excessive heat and humidity
- TAMPER EVIDENT PACKETS - DO NOT USE IF OPEN OR TORN
- Sinus Deacongestant Inactive ingredients
FD&C Blue #1, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid
Close - Sinus Decongestant Questions or Comments?
- Tetrahydrozoline HCL Active ingredient
- Tetrahydrozoline HCL Purpose
- Tetrahydroziline HCL Uses
- Tetrahydrozoline HCL Warnings
For external use only
When using this product- pupils may become enlarged temporarily
- overuse may produce increased redness of the eye
- remove contact lenses before using
- to avoid contamination, do not touch tip of container to any surface
- replace cap after using
Stop use and ask a doctor if
- you experience eye pain, changes in vision, continued redness or irritation of the eye
- the condition worsens or persists for more than 72 hours
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- Tetrahydrozoline HCL Directions
- Tetrahydrozoline HCL Other information
Store at 15° to 30°C (59° to 86°F)
- Tamper evident. Do not use this product if imprinted neckband is missing or broken.
- RETAIN THIS CARTON FOR FUTURE REFERENCE
Distributed by
North by Honeywell
900 Douglas Pike
Smithfield, RI 02917
Close - Tetrahydrozoline HCL Inactive ingredients
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride
Close - 4248 68600PROAM KIT CONTENTS
1 1X3 PLASTIC 100/BOX
1 WOVEN 2" X 3" 25/BOX
1 FINGERTIP 8 WOVEN 25/BOX
1 FINGERTIP "T" WOVEN 40/BOX
1 BUTTERFLY CLOS MED 100/BX DS
1 SWIFT KNUCKLE 40/BX
1 1 X 3 WOVEN 100/BOX
1 AMMONIA INHALANTS 10 PER
1 EYE DRESS PKT W/4 ADH STRIPS
2 GAUZE BANDAGE, 4" X 6 YD
1 INSTANT COLD PACK 4" X 6"
1 HYDROCORTISON,1.O%,1/32 OZ,10P
1 ELASTIC TAPE 1" X 5YD
1 O/H TAPE ADHESIVE TRI-CUT
2 GAUZE BANDAGE 1" x 2 YDS
2 GAUZE BANDAGE 2"X2 YDS STRETCH GZ
2 GAUZE BANDAGE 4"X2 YDS STRETCH GZ
1 FIRST AID GUIDE ASHI
2 BLOODSTOPPER
1 NON ADHERENT PADS 2"X3" 50'S
1 ABD COMBINE PAD 5" X 9"
1 GZE PADS STERILE 4"X 4" 25'S
1 CO-FLEX BANDAGE 2"X 5YDS TAN
1 CPR FILTERSHIELD 77-100
1 COTTON TIPS 100 PER VIAL
1 ANTISEPTIC WIPES BZK CHL 20'S
1 FIRST AID SPRAY AEROSOL 3 OZ
1 ALCOHOL WIPES 50'S
1 AYPANAL NON-ASP IND 2/ENV 250
1 PAIN STOPPERS IND PK 2ENV 250
1 MIRALAC TABS IND PK 2/ENV 250
1 BURN SPRAY 3 OZ
1 SINUS DECONGESTANT 2/ENV 100
1 TRIPLE BIOTIC .5 GRAM PKT 20
1 HYDROCORTISONE 1% .9 GRM 20'S
1 TETRASINE EYE DROPS 1/2 OZ
2 HAND & SKIN LOTION 1GM 20/BX
1 SWIFT-STAT BLOOD CLOTTER 3 OZ
1 COLD SPRAY 4 OZ
1 POISON OAK/IVY CLEANSER 4 OZ
1 COLD PACK 5"X9" BOXED
2 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 SPLINTER FORCEP 4 1/2"
1 SCISSOR LISTER BDG S/S 5 1/2"
1 POCKET INSERT RED #600 KIT
1 600 EMPTY KIT BLANK
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
2 2 PR LRG NITRILE GLVES ZIP BAG
6 WATER-JEL BURN DRESSING 2 X 6
6 WATER-JEL BURN DRESSING 2 X 2
2 TRI BNDG NON WOVEN 40"X40"X56"
1 STING Relief SWAB 10
1 RED BIO BAGS 2/BX
Close - Eyewash Principal Display Panel
- Ammonia Principal Display Panel
- Water Soluble 1st Aid Spray Principal Display Panel
- Burn Relief Water Soluble Principal Display Panel
- Triple Principal Display Panel
- Alcohol Principal Display Panel
- Miralac Principal Display Panel
- BZK Principal Display Panel
- Aypanal Principal Display Panel
- Hydrocortisone Principal Display Panel
- Sting Relief Principal Display Panel
- Pain Stopper Principal Display Panel
- Sinus Decongestant Principal Display Panel
- Tetrahydrozoline HCL Principal Display Panel
- 4248 Kit Label 68600PROAM
- INGREDIENTS AND APPEARANCE
4248 FIRST AID KIT
4248 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4248 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4248-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 BOTTLE 236 mL Part 2 10 AMPULE 3 mL Part 3 1 CAN 85 g Part 4 1 CAN 85 g Part 5 20 PACKET 10 g Part 6 50 POUCH 20 mL Part 7 125 PACKET 250 Part 8 20 PACKET 28 mL Part 9 125 PACKET 250 Part 10 30 PACKET 27 g Part 11 10 POUCH 4 mL Part 12 125 PACKET 250 Part 13 50 PACKET 100 Part 14 1 BOTTLE, DROPPER 15 mL Part 1 of 14 EYESALINE EMERGENCY EYEWASH
purified water liquidProduct Information Item Code (Source) NDC:0498-0100 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98.6 mL in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0100-02 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 12/18/2018 Part 2 of 14 AMMONIA INHALENT
ammonia inhalent inhalantProduct Information Item Code (Source) NDC:0498-3334 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA 0.045 g in 0.3 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-3334-00 0.3 mL in 1 AMPULE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/18/2018 Part 3 of 14 FIRST AID ANTISEPTIC WATER SOLUBLE
benzethonium chloride, benzocaine sprayProduct Information Item Code (Source) NDC:0498-0031 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.2 g in 100 g BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 10 g in 100 g Inactive Ingredients Ingredient Name Strength ISOBUTANE (UNII: BXR49TP611) BUTANE (UNII: 6LV4FOR43R) PROPANE (UNII: T75W9911L6) DIPROPYLENE GLYCOL (UNII: E107L85C40) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0031-40 85 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/19/2018 Part 4 of 14 BURN WATER SOLUBLE
benzocaine, benzethonium chloride, menthol sprayProduct Information Item Code (Source) NDC:0498-0021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.2 g in 100 g BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 10 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.33 g in 100 g Inactive Ingredients Ingredient Name Strength ISOBUTANE (UNII: BXR49TP611) BUTANE (UNII: 6LV4FOR43R) PROPANE (UNII: T75W9911L6) DIPROPYLENE GLYCOL (UNII: E107L85C40) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0021-40 85 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/12/2018 Part 5 of 14 TRIPLE ANTIBIOTIC
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointmentProduct Information Item Code (Source) NDC:0498-0750 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0750-36 0.5 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 09/19/2018 Part 6 of 14 ALCOHOL WIPE
isopropyl alcohol swabProduct Information Item Code (Source) NDC:0498-0143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0143-04 0.4 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/18/2018 Part 7 of 14 MIRALAC
calcium carbonate tabletProduct Information Item Code (Source) NDC:0498-0303 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 420 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITOL (UNII: 506T60A25R) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score 2 pieces Shape ROUND Size 11mm Flavor MINT Imprint Code FR8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 02/22/2012 Part 8 of 14 ANTISEPTIC TOWELETTE
benzalkonium chloride liquidProduct Information Item Code (Source) NDC:0498-0501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0501-00 1.4 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/22/2017 Part 9 of 14 AYPANAL NON-ASPIRIN
acetaminophen tabletProduct Information Item Code (Source) NDC:0498-2001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code circle;U Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/10/2012 Part 10 of 14 HYDROCORTISONE
anti-itch cream ointmentProduct Information Item Code (Source) NDC:0498-0800 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) LIGHT MINERAL OIL (UNII: N6K5787QVP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) PROPYLPARABEN (UNII: Z8IX2SC1OH) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CETYL ALCOHOL (UNII: 936JST6JCN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0800-35 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/06/2013 Part 11 of 14 STING RELIEF PAD
ethyl alcohol, lidocaine swabProduct Information Item Code (Source) NDC:0498-0733 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL in 1 mL Inactive Ingredients Ingredient Name Strength MENTHOL (UNII: L7T10EIP3A) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0733-00 0.4 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/23/2017 Part 12 of 14 PAIN STOPPERS
acetaminophen, caffeine, aspirin, salicylamide tabletProduct Information Item Code (Source) NDC:0498-2422 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 110 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.4 mg SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE 152 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 162 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE K30 (UNII: U725QWY32X) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color orange (BRIGHT ORANGE) Score no score Shape ROUND Size 11mm Flavor Imprint Code FR;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-2422-01 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/02/2017 Part 13 of 14 SINUS DECONGESTANT
phenylephrine tabletProduct Information Item Code (Source) NDC:0498-3331 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SHELLAC (UNII: 46N107B71O) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 27 (UNII: 2LRS185U6K) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color red Score no score Shape OVAL Size 11mm Flavor Imprint Code FR4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/18/2018 Part 14 of 14 EYE DROPS
tetrahydrozoline hydrochloride solution/ dropsProduct Information Item Code (Source) NDC:0498-0161 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE 0.05 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM BORATE (UNII: 91MBZ8H3QO) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 07/04/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 Labeler - Honeywell Safety Products USA, INC (079287321) Establishment Name Address ID/FEI Business Operations James Alexander 040756421 manufacture(0498-3334) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, INC 079287321 pack(0498-4248) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 manufacture(0498-2422, 0498-2001, 0498-0303, 0498-3331) Establishment Name Address ID/FEI Business Operations Dixon Investments 115315822 manufacture(0498-0031, 0498-0021) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0750, 0498-0800) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, Inc. 167518617 manufacture(0498-0100) Establishment Name Address ID/FEI Business Operations KC PharmaceuticLS, INC. 174450460 manufacture(0498-0161) Establishment Name Address ID/FEI Business Operations Changzhou Maokang Medical 421317073 manufacture(0498-0143, 0498-0501) Establishment Name Address ID/FEI Business Operations Safetec of America Inc 874965262 manufacture(0498-0733)