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

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

Do not use

in children less than 2 months of age
on open skin wounds

When using this product

Do not use in eyes. In case of contact with eyes, rinse with water.

Stop use and ask a doctor if

Irritation and redness persist.

Stop use and ask a doctor if

Irritation or redness persist.

Keep out of reach of children

If swallowed, get medical help promptly.

Directions

Place enough product on hands to cover all surfaces. Rub until dry.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Glycerine

Hydrogen Peroxide

Water

Questions/ Comments

Call 616-216-6395

Monday-Friday 8:00am-5:00pm EST

Package Label - Principal Display Panel

4oz 119mL NDC: 77163-616-04 Small Packaging

NDC: 77163-616-04 Small label

6oz 179mL NDC: 77163-616-06 Small Packaging

NDC: 77163-616-06 Small label

1/2 Gallon 1.89L NDC: 77163-616-64 Small Packaging

NDC: 77163-616-64 Retail front label NDC: 77163-616-64 Drug Facts back label

1 Gallon 3.78L NDC: 77163-616-01 Small Packaging

NDC: 77163-616-01 Retail Front Label NDC: 77163-616-01 Drug Facts back label

ALL HANDS CO. HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77163-616
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:77163-616-04	119 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/24/2020
2	NDC:77163-616-06	179 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/24/2020
3	NDC:77163-616-64	1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/24/2020
4	NDC:77163-616-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/24/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/24/2020

Labeler - Specified Coating Technologies LLC (034901858)

Name	Address	ID/FEI	Business Operations
Establishment
Specified Coating Technologies LLC		034901858	pack(77163-616) , label(77163-616) , repack(77163-616) , relabel(77163-616) , manufacture(77163-616)