NDC | 0498-0021-40, 0498-0031-40, 0498-0100-02, 0498-0114-01, 0498-0143-04, 0498-0501-00, 0498-0750-36, 0498-3334-00, 0498-4240-01 |
Set ID | 85809d69-3b29-1e7f-e053-2a91aa0a3e16 |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, INC |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
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.
- Eyewash Directions
- Eyewash Inactive ingredients
- Eyewash Questions
- Aspirin Active ingredient (in each tablet)
- Aspirin Purpose
- Aspirin Uses
-
Aspirin
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
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
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
- you are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout or arthritis
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- ringing in the ears or loss of hearing occurs
- any new symptoms appear
If pregnant or breast-feeding,
If pregnant or breat-feeding, ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- Aspirin Directions
- Aspirin Other information
- Aspirin Inactive ingredients
- Aspirin Questions or Comments
- Ammonia Active ingredient
- Ammonia Purpose
- Ammonia Uses
- Ammonia Warnings
- Ammonia Directions
- 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
-
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
- Water Soluble 1st Aid Spray Directions
- Water Soluble 1st Aid pray Other information
- Water Soluble 1st Aid pray Inactive ingredients
- Burn Relief Water Soluble Active ingredients
- Burn Relief Water Soluble Purpose
- Burn Relief Water Soluble Uses
-
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
- Burn Relief Water Soluble Directions
- Burn Relief Water Soluble Other information
- Burn Relief Water Soluble Inactive ingredients
- Triple Active ingredients
- Triple Purpose
- Triple Uses
- Triple Warnings
- Triple Directions
- Triple Other information
- Triple Inactive ingredient
- Alcohol Active ingredient
- Alcohol Purpose
- Alcohol Uses
- Alcohol Warnings
- Alcohol Directions
- Alcohol Other information
- Alcohol Inactive ingredient
- Miralac Active ingredient (in each chewable tablet)
- Miralac Active ingredient (in each chewable tablet)
- Miralac Purpose
- Miralac Uses
-
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
- Miralac Directions
- Miralac Other information
- 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
- BZK Directions
- BZK Other information
- BZK Inactiave ingredient
- BzK Questions
- Aypanal Active ingredient
- Aypanal Purpose
- Aypanal Uses
-
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
- Aypanal Other information
- Aypanal Inactive igredients
- Aypanal Questions or Comments
-
4240
68400LNODEA KIT CONTENTS
1 3/4 X 3 PLAS 100/BOX
1 1X3 PLASTIC 100/BOX
1 WOVEN 2" X 3" 25/BOX
1 FINGERTIP "T" WOVEN 40/BOX
1 1X3 WOVEN SING 50/BOX
1 SWIFT KNUCKLE 40/BX
1 AMMONIA INHALANTS 10 PER
1 ELASTIC TAPE 1" X 5YD
1 FORCEPS POINTED METAL
1 O/H TAPE ADHESIVE TRI-CUT
1 FIRST AID GUIDE ASHI
6 GAUZE CLEAN-WRAP BDGE N/S 2"
2 BLOODSTOPPER
1 NON ADHERENT PADS 2"X3" 50'S
2 GZE PADS STERILE 2"X 2" 25'S
1 GZE PADS STERILE 4"X 4" 25'S
1 CO-FLEX BANDAGE 2"X 5YDS TAN
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 ASPIRIN IND PK 5 GR 2/ENV 250
1 AYPANAL NON-ASP IND 2/ENV 100
1 MIRALAC TABS IND PK 2/ENV 250
1 BURN SPRAY 3 OZ
1 TRIPLE BIOTIC .5 GRAM PKT 20
1 COLD PACK 5"X9" BOXED
1 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 SCISSOR BDGE 4" RED PLS HDL
1 400 EMPTY KIT BLANK
1 POCKET INSERT RED #400 KIT 5R
1 TONGUE BLADES SR WRAPPED 6'S
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
2 PR LRG NITRILE GLVES ZIP BAG
2 TRI BNDG NON WOVEN 40"X40"X56"
1 RED BIO BAGS 2/BX
- Eyewash Principal Display Panel
- Aspirin 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
- 4240 Kit Label 68400LNODEA
-
INGREDIENTS AND APPEARANCE
4240 FIRST AID KIT
4240 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4240 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4240-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 125 PACKET 250 Part 2 1 BOTTLE 118 mL Part 3 125 PACKET 250 Part 4 10 AMPULE 3 mL Part 5 1 CAN 85 g Part 6 1 CAN 85 g Part 7 20 PACKET 10 g Part 8 50 POUCH 20 mL Part 9 20 PACKET 28 mL Part 10 50 PACKET 100 Part 1 of 10 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 2 of 10 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 3 of 10 ASPIRIN
aspirin tabletProduct Information Item Code (Source) NDC:0498-0114 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) MINERAL OIL (UNII: T5L8T28FGP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code FR21 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0114-01 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 09/18/2018 Part 4 of 10 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 5 of 10 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 6 of 10 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 7 of 10 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 8 of 10 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 9 of 10 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 10 of 10 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 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(0498-4240) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 manufacture(0498-0114, 0498-2001, 0498-0303) 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) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, Inc. 167518617 manufacture(0498-0100) Establishment Name Address ID/FEI Business Operations Changzhou Maokang Medical 421317073 manufacture(0498-0143, 0498-0501)