NDC | 0498-0143-04, 0498-0750-36, 0498-2422-01, 0498-3334-00, 0498-4229-01 |
Set ID | 84c3c334-fe39-ca33-e053-2991aa0aba80 |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, INC |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number |
- Ammonia Inhalent Active ingredient
- Ammonia Inhalent Purpose
- Ammonia Inhalent Uses
- Ammonia Inhalent Warnings
- Ammonia Inhalent Directions
- Ammonia Inhalent Other information
- Ammonia Inhalent Other information
- Ammonia Inhalent Inactive ingredients
- Ammonia Inhalent Questions or Comments
- Alcohol Wipe Active ingredient
- Alcohol Wipe Purpose
- Alcohol Wipe Uses
- Alcohol Wipe Warnings
- Alcohol Wipe Directions
- Alcohol Wipe Other information
- Alcohol Wipe Inactive ingredient
- Alcohol Wipe Questions
- Aypanal Active ingredient
- Aypanal Purpose
- Aypanaly 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
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken 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 a skin rash 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.
-
Aypanal
Directions
do not take more than directed (see overdose warning)
adults and children 12 years of age or older
- take two tablets every 4-6 hours while symptoms last
- do not take more than 12 tablets in 24 hours
children 6 to under 12 years of age
- take 1 tablet every 4-6 hours while symptoms last
- do not take more than 5 tablets in 24 hours
children under 6 years consult a doctor
- Aypanal Other information
- Aypanal Inactive ingredients
- Aypanal Questions
- Triple Active ingredient
- Triple Purpose
- Triple Uses
- Triple Warnings
- Triple Directions
- Triple Other information
- Triple Inactive ingredient
- Pain Stoppers Active ingredient
- Pain Stoppers Purpose
- Pain Stoppers Uses
-
Pain Stoppers
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 productStomach 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 use 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.
- Pain Stoppers Directions
- Pain Stoppers Other information
- Pain Stoppers Inactive ingredients
- Pain Stoppers Questions or Comments?
-
4229
68140FEDX Kit Contents
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 NITRILE GLOVES 2PR BBP
1 ADHESIVE TAPE W/P 1" X 10YDS
1 GAUZE BANDAGE 2"X2 YDS STRETCH GZ
1 FIRST AID GUIDE ASHI
1 BLOODSTOPPER
1 CTA STRL 6" SGL TIP 12/2
1 ALCOHOL WIPES 50'S
1 AYPANAL NON-ASP IND 2/ENV 100
1 PAIN STOPPERS IND PK 2ENV 250
1 TRIPLE BIOTIC .5 GRAM PKT 20
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 F A KIT EMPTY BLANK 140
LBL STOCK 6-3/8"X4"
1 LBL STOCK 3"x1-7/8"
1 TRI BNDG NON WOVEN 40"X40"X56"
- Ammonia inhalent Principal Display Panel
- Alcohol Wipe Principal Display Panel
- Aypanal Principal Display Panel
- Triple Principal Display Panel
- Pain Stoppers Principal Display Panel
- 4229 Kit Label 68410FEDX
-
INGREDIENTS AND APPEARANCE
4229 FIRST AID KIT
4229 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4229 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4229-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 20 PACKET 10 g Part 2 125 PACKET 250 Part 3 10 AMPULE 3 mL Part 4 50 POUCH 20 mL Part 5 50 PACKET 100 Part 1 of 5 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 NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] 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 2 of 5 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 ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 162 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.4 mg SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE 152 mg Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE K30 (UNII: U725QWY32X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 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 3 of 5 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 4 of 5 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 5 of 5 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(0498-4229) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 manufacture(0498-2001, 0498-2422) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0750) Establishment Name Address ID/FEI Business Operations Changzhou Maokang Medical 421317073 manufacture(0498-0143)