Label: 4191 FIRST AID KIT- 4191 first aid kit
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NDC Code(s):
0498-0100-01,
0498-0121-00,
0498-0203-00,
0498-0733-00, view more0498-4191-01
- 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 December 29, 2022
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
- 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
- Sting Relief Active ingredient (in each wipe)
- Sting Relief Purpose
- Sting Relief Uses
- Sting Relief Warnings
- Sting Relief Directions
- Sting Relief Inactive ingredient
- Sting Relief Questions or Comments?
- PVP Active ingredient
- PVP Purpose
- PVP Uses
- PVP Warnings
- PVP Directioons
- PVP Other information
- PVP Inactive ingredients
- PVP Questions and Comments?
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4191
010875-0349 Kit Contents
1 KNUCKLE BAND 8 PER
1 AMMONIA INHALANTS 10 PER
1 GAUZE BANDAGE, 4" X 6 YD
1 TOURNIQUET, 1 PER
1 TRIANGULAR BDG, NON-STERILE
1 WIRE SPLINT 1 PER
1 GAUZE COMP, 1 SQ YARD, 1 PER
1 BANDAGE COMP, 2" OFFSET, 4 PER
1 BANDAGE COMP, 4" OFFSET, 1 PER
1 ADHESIVE BDG,PLSTIC,1"X3"16PER
1 FINGERTIP BANDAGE, 10 PER
1 1 OZ EYE WASH W/PADS & STRIPS
1 BURN JEL 1/8 OZ, 6 PER
2 PVP IODINE WIPES 10 PER
LBL STOCK 6-3/8"X4"
1 LBL STOCK 3"x1-7/8"
1 LBL CONTS 6 3/4"X3 1/2" ID B
1 KIT STL 16 UN (VERTICAL)
1 INSERT FA INSTR 16UN PHIL ELEC
1 58 LBL REFILL 010875-0349
1 NOX A STING WIPES 10
- Principal Display Panel
- Burn Jel Principal Display Panel
- Sting Relief Principal Display Panel
- PVP Principal Display Panel
- 4191 Kit Label 010875-0349
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INGREDIENTS AND APPEARANCE
4191 FIRST AID KIT
4191 first aid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4191 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4191-01 1 in 1 KIT 09/13/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 PACKET 21 g Part 2 10 POUCH 4 mL Part 3 20 POUCH 6 mL Part 4 1 BOTTLE 30 mL Part 1 of 4 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 2 of 4 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 BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) MENTHOL (UNII: L7T10EIP3A) 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 3 of 4 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 4 of 4 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. (118768815)