Label: 4224 FIRST AID KIT- 4224 first aid
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NDC Code(s):
0498-0100-01,
0498-0114-01,
0498-0121-00,
0498-0203-00,
view more0498-3334-00, 0498-4224-01
- Packager: Honeywell Safety Products USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated March 22, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Keep out of reach of children
- 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
- Other information
- Inactive ingredients
- Questions or Comments
- Burn Jel Active ingredient
- Burn Jel Purpose
- Burn Jel Uses
- Burn Jel Warnings
For external use only
Stop use and ask a doctor if
- the condition gets worse
- symptoms persist for more than 7 days
- condition clears up and recurs within a few days
CloseKeep out of reach of children
- If swallowed, get medical help or contact a Poison Control Center right away.
- Burn JEl Directions
- adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: ask a doctor
- you may report a serious reaction to this product to 800-430-5490
- Burn Jel Other information
- Burn Jel Inactive ingredients
carbopol 940, carbopol 1342, diazolidinyl urea, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, trolamine, water
Close - Burn Jel Questions
- PVP Active ingredient
- PVP Purpose
- PVP Uses
- PVP Warnings
For external use only
Do not use
- in the eyes
- over large areas of the body
- on individuals who are allergic or sensitive to iodine
CloseKeep out of reach of children
- If swallowed, get medical help or contact a Poison Control Center right away
- PVP Directioons
Reverse cardboard sleeve, then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.
- clean affected area
- apply to affected area 1 to 3 times daily
- may be covered with a sterile bandage
- discard swab after single use
- PVP Other information
- store at room temperature away from light
- keep from freezing or excessive heat
- do not use if package is torn or open
- PVP Inactive ingredients
- PVP Questions and Comments?
- Aspirin Active ingredient
- Aspirin Purpose
- Aspirin Uses
temporarily reduces fever and relieves minor aches and pains associated with:
- a cold
- headache
- toothache
- muscular aches
- backache
- minor pain of arthritis
- premenstrual and menstrual periods
- 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.
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Keep out of reach of childrenIn case of overdose, get medical help or contact Poison Control Center right away.
- Aspirin Directions
- drink a full glass of water with each dose
- adults and children 12 years of age and older: take 1 or 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
- children under 12 years of age: consult a doctor
- Aspirin Other information
store at room temperature 15° - 30°C (59° - 86°F)
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TAMPER EVIDIENT PACKETS - DO NOT USE IF OPEN OR TORN - Aspirin Inactive ingredients
corn starch, croscarmellose sodium*, hypromellose*, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, povidone, propylene glycol, silicon dioxide, stearic acid*, titanium dioxide*
*may contain these ingredients
Close - Aspirin Questions or Comments?
- 4224 35824CG Kit Contents
1 AMMONIA INHALANTS 10 PER
2 GAUZE BANDAGE, 4" X 6 YD
1 TOURNIQUET, 1 PER
1 WIRE SPLINT 1 PER
2 GAUZE COMPRESS, 1728 SQ IN 1
2 BUFFERED EYE WASH 1 OZ BTL
2 ADHESIVE BDG,PLSTIC,1"X3"16PER
2 BURN JEL 1/8 OZ, 6 PER
1 PVP IODINE WIPES 10 PER
2 BANDAGE COMP 2" W/TELFA PAD 4
3 BANDAGE COMP 4" W/TELFA PAD 1
LBL STOCK 6-3/8"X4"
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 3"x1-7/8"
4 BAYER 12 PACK PER ZIP BAG
24 UNIT PLASTIC HIPS MT BLANK
1 ADHES TAPE EYE STRIPS 2'S
2 TRI BNDG NON WOVEN 40"X40"X56"
Close - Principal Display Panel
- Burn Jel Principal Display Panel
- PVP Principal Display Panel
- Aspirin Principal Display Panel
- 4224 Kit Label 35824CG
- INGREDIENTS AND APPEARANCE
4224 FIRST AID KIT
4224 first aid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4224 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4224-01 1 in 1 KIT 09/13/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 24 PACKET 48 Part 2 10 AMPULE 3 mL Part 3 12 PACKET 42 g Part 4 10 POUCH 3 mL Part 5 2 BOTTLE 60 mL Part 1 of 5 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) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) MINERAL OIL (UNII: T5L8T28FGP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) 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 2 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 3 of 5 BURN JEL
gel for burns gelProduct Information Item Code (Source) NDC:0498-0203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2 g in 100 g Inactive Ingredients Ingredient Name Strength TEA TREE OIL (UNII: VIF565UC2G) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) PROPYLPARABEN (UNII: Z8IX2SC1OH) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) DIPROPYLENE GLYCOL (UNII: E107L85C40) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0203-00 3.5 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 not final part348 09/19/2018 Part 4 of 5 PVP IODINE WIPE
povidone-iodine 10% swabProduct Information Item Code (Source) NDC:0498-0121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0121-00 0.3 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 unapproved drug other 09/18/2018 Part 5 of 5 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, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0100-01 30 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/13/2018 Labeler - Honeywell Safety Products USA, Inc. (079287321) Registrant - 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(0498-4224) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 manufacture(0498-0114) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0203) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, Inc. 167518617 manufacture(0498-0100) CloseEstablishment Name Address ID/FEI Business Operations Sion Biotext Medical 532775194 manufacture(0498-0121)
