Hand Sanitizer Alcohol Antiseptic 80%

Hand Sanitizer 80% by

Drug Labeling and Warnings

Hand Sanitizer 80% by is a Otc medication manufactured, distributed, or labeled by Direct Packaged Ingredients (DPI), LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER 80%- alcohol 80% gel 
Direct Packaged Ingredients (DPI), LLC

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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Hand Sanitizer Alcohol Antiseptic 80%

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. 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

glycerin, hydrogen peroxide, purified water USP

Hand Sanitizer 80% - 1000 ml

HS 80% Ethanol Unscented 1000ml80% Alcohol Unscented000 mL NDC: 00000-000-00

HAND SANITIZER 80% 
alcohol 80% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80656-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC) 0.332 g  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.045 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80656-200-013785.41 mL in 1 JUG; Type 0: Not a Combination Product03/30/2020
2NDC: 80656-200-03946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/11/2020
3NDC: 80656-200-041000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/12/2020
4NDC: 80656-200-051000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202006/23/2021
Labeler - Direct Packaged Ingredients (DPI), LLC (557016024)
Establishment
NameAddressID/FEIBusiness Operations
Direct Packaged Ingredients (DPI), LLC557016024manufacture(80656-200) , label(80656-200) , pack(80656-200)

Revised: 11/2021
Document Id: cffc22a8-6abd-ecf6-e053-2995a90aae3f
Set id: b21fb8b4-fe28-09c3-e053-2995a90a3130
Version: 6
Effective Time: 20211104