Label: 4391 FIRST AID KIT- 4391 first aid kit
- NDC Code(s): 0498-0121-00, 0498-0143-04, 0498-0733-00, 0498-4391-01
- 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 30, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Sting Relief Active ingredient (in each wipe)
- Sting Relief Purposse
- Sting Relief Uses
- Sting Relief Warnings
- Sting Relief Directions
- Sting Relief Inactive ingredients
- Sting Relief Questions or Comments?
- Hydrocortisone Active ingredient (in each gram)
- Hydrcortisone Purpose
- Hydrocortisone Uses
-
Hydrocortisone
Warnings
For external use onlyWhen using the product
- avoid contact with eyes
- do not begin use of any other hydrocortisone product unless you have consulted a doctor
- do not use for the treatment of diaper rash
- Hydrocortisone Directions
- Hydrocortisone Other information
- Hydrocortisone Inactive ingredients
- Hydrocortisone Questions or Comments?
- Alcohol Active ingredient
- Alcohol Purpose
- Alcohol Uses
- Alcohol Warnings
- Alcohol Directions
- Alcohol Other information
- Alcohol Inactive ingredient
- Alcohol Questions
- PVP Active ingredient
- PVP Purpose
- PVP Uses
- PVP Warnings
- PVP Directions
- PVP Other information
- PVP Inactive ingredients
-
4391
SF00003659/M Kit Contents
1 KNUCKLE BAND 8 PER
2 TRIANGULAR BDG, NON-STERILE
1 ADH TAPE, .5" X 2.5 YD, 2 PER
1 FORCEPS & SCISSORS, 1 EA
2 GAUZE BANDAGE, 2" X 6 YD,2 PER
1 GAUZE COMP, 1 SQ YARD, 1 PER
1 INSTANT COLD PACK 4" X 6"
1 BANDAGE COMP, 2" OFFSET, 4 PER
1 BANDAGE COMP, 4" OFFSET, 1 PER
1 FINGERTIP BANDAGE, 10 PER
2 WATER JEL DRESSING, 2" X 2"
2 WATER JEL DRESSING,2" X 6"
1 ALCOHOL PREP PADS 10P
1 HYDROCORTISON,1.O%,1/32 OZ,10P
3 PVP IODINE WIPES 10 PER
1 IVYX CLEANSER TOWEL 5 PER
1 NITRILE GLOVES 2PR BBP
2 ADH BDG, CLOTH, 1"X3", 16 PER
1 CPR FILTERSHIELD 77-100
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
1 LABEL NORTH CONTENTS 8X8 ID B
1 KIT STL 36 UN WHT 01 HOR SHELF
1 LBL 36U CVR NORTH ID C.
1 STING Relief WIPES 10
- Sting Relief Principal Display Panel
- Hydrocortisone Principal Display Panel
- Alcohol Principal Display Panel
- PVP Principal Display Panel
- 4391 Kit Label SF00003659/M
-
INGREDIENTS AND APPEARANCE
4391 FIRST AID KIT
4391 first aid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4391 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4391-01 1 in 1 KIT 09/13/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 10 POUCH 4 mL Part 2 10 POUCH 4 mL Part 3 10 PACKET 9 g Part 4 30 POUCH 9 mL Part 5 10 PACKET 9 g Part 1 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 2 of 5 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 5 HYDROCORTISONE
anti-itch cream ointmentProduct Information Item Code (Source) NDC:0498-0800 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CETYL ALCOHOL (UNII: 936JST6JCN) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) TROLAMINE (UNII: 9O3K93S3TK) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.9 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 03/06/2013 10/15/2019 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 WATER (UNII: 059QF0KO0R) NONOXYNOL-9 (UNII: 48Q180SH9T) 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 HYDROCORTISONE
anti-itch creamProduct Information Item Code (Source) NDC:0498-0801 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) TROLAMINE (UNII: 9O3K93S3TK) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CETYL ALCOHOL (UNII: 936JST6JCN) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.9 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 10/15/2019 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)