Label: 4192 FIRST AID KIT- 4192 first aid kit
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- NDC Code(s): 0498-0121-00, 0498-0203-00, 0498-3334-00, 0498-4192-01
- 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 9, 2019
If you are a consumer or patient please visit this version.
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- Active ingredient
- Purpose
- Uses
- Warnings
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions or Comments
- Burn Jel Active ingredient
- Burn Jel Purpose
- Burn Jel Uses
- Burn Jel Warnings
- Burn JEl Directions
- Burn Jel Other information
- Burn Jel Inactive ingredients
- Burn Jel Questions
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4192
011077-4258 Kit Contents
1 KNUCKLE BAND 8 PER
2 AMMONIA INHALANTS 10 PER
1 EYE DRESS PKT W/4 ADH STRIPS
2 GAUZE BANDAGE, 4" X 6 YD
2 TRIANGULAR BDG, NON-STERILE
2 GAUZE PADS, 3" X 3", 4 PER
1 ADH TAPE, .5" X 2.5 YD, 2 PER
1 INSTANT COLD PACK 4" X 6"
2 BANDAGE COMP, 2" OFFSET, 4 PER
2 BANDAGE COMP, 4" OFFSET, 1 PER
2 BURN JEL 1/8 OZ, 6 PER
3 PVP IODINE WIPES 10 PER
3 ADH BDG, CLOTH, 1"X3", 16 PER
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
1 KIT STL 24 UN WHITE 01
1 LABL INSTR 24 & 36 UNIT KITS
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- 4192 Kit Label 011077-4258
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INGREDIENTS AND APPEARANCE
4192 FIRST AID KIT
4192 first aid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4192 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4192-01 1 in 1 KIT 09/13/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 20 AMPULE 6 mL Part 2 12 PACKET 42 g Part 3 30 POUCH 9 mL Part 1 of 3 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 2 of 3 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 3 of 3 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 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(0498-4192) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0203) Establishment Name Address ID/FEI Business Operations Sion Biotext Medical 532775194 manufacture(0498-0121)
