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Hand Sanitizer Blend 1

Medically reviewed by Drugs.com. Last updated on May 19, 2020.

Dosage form: liquid
Ingredients: ALCOHOL 80mL in 100mL
Labeler: Dimachem Inc
NDC Code: 78158-001

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

Package Label - Principal Display Panel

946 ml NDC: 78158-001-01

3.78 L NDC: 78158-001-02

20 L NDC: 78158-001-03

205 L NDC: 78158-001-04

1025 L NDC: 78158-001-05

HAND SANITIZER BLEND 1 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78158-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN1.45 mL  in 100 mL
HYDROGEN PEROXIDE0.125 mL  in 100 mL
WATER 
Packaging
#Item CodePackage Description
1NDC:78158-001-01946 mL in 1 BOTTLE
2NDC:78158-001-023780 mL in 1 JUG
3NDC:78158-001-0320000 mL in 1 PAIL
4NDC:78158-001-04205000 mL in 1 DRUM
5NDC:78158-001-051025000 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/19/2020
Labeler - Dimachem Inc (249772141)
Establishment
NameAddressID/FEIOperations
Dimachem Inc249772141manufacture(78158-001)

 
Dimachem Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.