Essential hand sanitizer liquid

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:

  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

Otc - when using section

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.

Otc - stop use section

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - keep out of reach of children section

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

Ingredients and appearance - Product information

Essential hand sanitizer liquid- Alcohol

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 77853-000
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Alcohol ( UNII: 3K9958V90M)( Alcohol - UNII: 3K9958V90M ) 80 mLin 100 mL

Inactive Ingredients

Ingredient Name Code
Glycerin ( UNII: PDC6A3C0OX)
Hydrogen peroxide ( UNII: BBX060AN9V)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 77853-000-02 3785mL in 1 BOTTLE 2020/03/30

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part333A USA 2020/03/30

Labeler - reX Solutions LLC( 117513438)

Establishment

Name ID/FEI Business Operations
reX Solutions LLC 117513438 manufacture( 77853-000)