Label: ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION- alcohol solution
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NDC Code(s):
47593-624-11,
47593-624-12,
47593-624-16,
47593-624-21, view more47593-624-23, 47593-624-35, 47593-624-38, 47593-624-65, 47593-624-91
- Packager: Ecolab Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 15, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
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:
- 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.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- 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)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- INACTIVE INGREDIENT
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION
alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47593-624 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 L in 100 L Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47593-624-12 18.9 L in 1 PAIL; Type 0: Not a Combination Product 04/14/2020 03/15/2024 2 NDC:47593-624-16 18.9 L in 1 PAIL; Type 0: Not a Combination Product 10/13/2021 3 NDC:47593-624-21 208 L in 1 DRUM; Type 0: Not a Combination Product 04/14/2020 4 NDC:47593-624-65 0.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/14/2020 10/13/2021 5 NDC:47593-624-38 0.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/13/2021 6 NDC:47593-624-23 0.946 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/14/2020 10/13/2023 7 NDC:47593-624-91 1272 L in 1 CONTAINER; Type 0: Not a Combination Product 04/14/2020 8 NDC:47593-624-35 2000 L in 1 CONTAINER; Type 0: Not a Combination Product 04/14/2020 9 NDC:47593-624-11 3.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 04/14/2020 03/31/2024 Labeler - Ecolab Inc. (006154611) Registrant - Ecolab Inc. (006154611)