Label: HAND SANITIZER- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 74184-001-15 - Packager: The Lab LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated August 26, 2020
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured per guidance outlined in the final ruling of 21 CFR Part 310- Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. 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):
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v))
- Glycerin 98% (0.015% v/v).
- Hydrogen peroxide 3% (0.04% v/v).
- Sterile distilled water or boiled cold water (19.9% v/v).
- Acrylates Copolymer (rheology modifier) (0.05% v/v).
- Triethanolamine (pH neutralizer) (0.005% v/v).
- Active Ingredient(s)
- Purpose
- Uses
- Warnings
- Do not use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse 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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74184-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID) 0.005 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.015 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.04 mL in 100 mL WATER (UNII: 059QF0KO0R) 19.9 mL in 100 mL PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N) 0.05 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74184-001-15 3785 mL in 1 JUG; Type 0: Not a Combination Product 05/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/06/2020 Labeler - The Lab LLC (092838384) Establishment Name Address ID/FEI Business Operations The Lab LLC 092838384 manufacture(74184-001)
