HAND SANITIZER- alcohol liquid 
Community Chemical

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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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

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

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

330 gal Hand Sanitizer gel 330 gal Hand Sanitizer

55 gal Hand Sanitizer liquid 55 gal Hand Sanitizer liquid

55 gal Hand Sanitizer gel 55 gal Hand Sanitizer gel

1 gal Hand Santizer liquid 1 gal Hand Sanitizer liquid

1 gal Hand Sanitizer gel 1 gal Hand Sanitizer gel

32 oz Hand Sanitizer liquid 32 oz Hand Sanitizer liquid

32 oz Hand Sanitizer gel

32 oz Hand Sanitizer gel

8 oz Hand Sanitizer gel 8 oz Hand sanitizer gel

8 oz Hand Sanitizer liquid 8 oz Hand Sanitizer liquid

4 oz Hand Sanitizer liquid

4 oz Hand Sanitizer liquid

4 oz Hand Sanitizer gel

4 oz Hand Sanitizer gel2 oz Hand Sanitizer gel

2 oz Hand Sanitizer gel

2 oz Hand Sanitizer liquid

2 oz Hand Sanitizer liquid

32 oz Hand Sanitizer gel NDC 77386-903-14

32 oz Hand Sanitizer liq NDC 77386-903-04

1 gal Hand Sanitizer gel NDC 77386-903-15

1 gal Hand Sanitizer liq NDC 77386-903-05

55 gal Hand Sanitizer gel NDC 77386-903-16

55 gal Hand Sanitizer liq NDC 77386-903-06

330 gal Hand Sanitizer gel NDC 77386-903-17

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77386-903
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77386-903-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:77386-903-04946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:77386-903-053785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:77386-903-06208198 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
5NDC:77386-903-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:77386-903-12118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
7NDC:77386-903-13236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
8NDC:77386-903-14946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
9NDC:77386-903-153785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
10NDC:77386-903-16208198 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
11NDC:77386-903-171248185 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
12NDC:77386-903-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
13NDC:77386-903-1159 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Community Chemical (609299839)
Establishment
NameAddressID/FEIBusiness Operations
Community Chemical609299839manufacture(77386-903)

Revised: 1/2022
Document Id: d5cc96b5-2fd4-fe2b-e053-2995a90af06a
Set id: a3d3286a-6279-9f12-e053-2995a90a2be0
Version: 5
Effective Time: 20220117
 
Community Chemical