HAND SANITIZER WHO FORMULATION- alcohol liquid

Hand Sanitizer WHO Formulation by

Drug Labeling and Warnings

Hand Sanitizer WHO Formulation by is a Otc medication manufactured, distributed, or labeled by AMASS Brands, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

80% Ethyl Alcohol (v/v); Purpose: Antiseptic

Use

Hand sanitizer to help reduce disease-causing bacteria.

Warnings

Flammable. Keep away from heat or flame. For external use only.

Do not use

• on children less than 2 months of age or on open skin wounds. Do not use in or near the eyes. in case of eye contact, rinse thoroughly with water.

WHEN USING

Stop use and ask a doctor if irritation or rash occurs.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a poison center immediately.

Other information

• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water

Use

Hand sanitizer to help reduce disease-causing bacteria.

DOSAGE & ADMINISTRATION

Apply liberally to dry hands, rub briskly until evaporated.
Children should be supervised when using this product.

Package Label - Principal Display Panel

80% ALCOHOL ANTISEPTIC TOPICAL SOLUTION

Antiseptic Hand Rub Non-Sterile Solution

12 oz | 355 mL

80% Alcohol v/v

INGREDIENTS AND APPEARANCE

HAND SANITIZER WHO FORMULATION 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77419-0002
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77419-0002-2	118.294 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/30/2020
2	NDC: 77419-0002-1	59.1471 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/30/2020
3	NDC: 77419-0002-3	354.882 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - AMASS Brands, Inc (121284034)

Establishment
Name	Address	ID/FEI	Business Operations
AMASS Brands, Inc		121284034	manufacture(77419-0002)