ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION- alcohol solution 
Ecolab Inc.

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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 80% v/v (equivalent to 73.53% w/w)

Purpose

Antiseptic

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.

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)
  • for emergency medical information call 1-800-328-0026

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

Alcohol Antiseptic 80%
Topical Solution
Hand Sanitizer
Non-sterile Solution

5 US Gal (18.9L)

Ecolab Inc 1 Ecolab Place

St. Paul, MN 55102 (USA)

representative label

representative label

ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-624
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47593-624-1218.9 L in 1 PAIL; Type 0: Not a Combination Product04/14/202003/15/2024
2NDC:47593-624-1618.9 L in 1 PAIL; Type 0: Not a Combination Product10/13/2021
3NDC:47593-624-21208 L in 1 DRUM; Type 0: Not a Combination Product04/14/2020
4NDC:47593-624-650.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/202010/13/2021
5NDC:47593-624-380.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/13/2021
6NDC:47593-624-230.946 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/202010/13/2023
7NDC:47593-624-911272 L in 1 CONTAINER; Type 0: Not a Combination Product04/14/2020
8NDC:47593-624-352000 L in 1 CONTAINER; Type 0: Not a Combination Product04/14/2020
9NDC:47593-624-113.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)04/14/202003/31/2024
Labeler - Ecolab Inc. (006154611)
Registrant - Ecolab Inc. (006154611)

Revised: 3/2024
 
Ecolab Inc.