WHO RECOMMENDED HAND RUB by Brenntag Great Lakes, LLC

Drug Details [pdf]

WHO RECOMMENDED HAND RUB- alcohol liquid
Brenntag Great Lakes, 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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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:

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.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
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

Name

WHO RECOMMENDED HAND RUB
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51341-4934
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 51341-4934-1	26000000 mL in 1 TANK; Type 0: Not a Combination Product	07/06/2020
2	NDC: 51341-4934-2	1040988 mL in 1 TANK; Type 0: Not a Combination Product	07/06/2020
3	NDC: 51341-4934-3	208198 mL in 1 DRUM; Type 0: Not a Combination Product	07/06/2020
4	NDC: 51341-4934-4	18927.1 mL in 1 PAIL; Type 0: Not a Combination Product	07/06/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/06/2020	07/07/2020

Labeler - Brenntag Great Lakes, LLC (106892164)

Registrant - Brenntag Great Lakes, LLC (106892164)

Name	Address	ID/FEI	Business Operations
Establishment
Brenntag Great Lakes, LLC		106892164	manufacture(51341-4934)

Revised: 4/2021

Document Id: c1233155-19a3-b573-e053-2a95a90a4617

Set id: a9dc96c7-1fc4-e2f8-e053-2995a90a629a

Version: 5

Effective Time: 20210429