75% Ethyl Alcohol Gelled Formula - CONSUMER

75% Ethyl Alcohol Gel Sanitizer by

Drug Labeling and Warnings

75% Ethyl Alcohol Gel Sanitizer by is a Otc medication manufactured, distributed, or labeled by Griffin Shoe Care Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

75% ETHYL ALCOHOL GEL SANITIZER- alcohol liquid 
Griffin Shoe Care Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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75% Ethyl Alcohol Gelled Formula - CONSUMER

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Acrylates Copolymer, Fragrance, Aminoethyl Propanol

Package Label - Principal Display Panel

59.1 mL NDC: 74887-500-02 59.1 ml label

236.5 mL NDC: 74887-500-08 236.5 ml label

3785.4 mL NDC: 74887-500-10 3785.41 ml label

75% ETHYL ALCOHOL GEL SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74887-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 4.5 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.14 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74887-500-0259.1 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/202007/13/2020
2NDC: 74887-500-08236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/202007/13/2020
3NDC: 74887-500-103785.4 mL in 1 JUG; Type 0: Not a Combination Product05/13/202007/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/13/202007/13/2020
Labeler - Griffin Shoe Care Company (079243125)

Revised: 12/2021
Document Id: d296d0bc-6386-60c0-e053-2995a90aadc0
Set id: a7211e33-7269-062b-e053-2995a90ae71d
Version: 5
Effective Time: 20211207