4 HANDS SANITIZER- hand sanitizer solution 
4 Hands Brewing Company, 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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4 Hands Sanitizer

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.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentag
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Toba
b. Glycerol (1.45% v/v).
c. Hydrogen peroxide (0.125% v/v).
d. 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

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Indications & Usage

Warnings

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

Do Not Use

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

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

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

1 GAL Healthcare Personnel Ethyl Alcohol Hand Sanitizer

Principal Display Panel

4 HANDS SANITIZER 
hand sanitizer solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73951-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73951-0001-13785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product03/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/23/2020
Labeler - 4 Hands Brewing Company, LLC (007369485)
Registrant - 4 Hands Brewing Company, LLC (007369485)
Establishment
NameAddressID/FEIBusiness Operations
4 Hands Brewing Company, LLC007369485manufacture(73951-0001)

Revised: 4/2020
Document Id: a3497488-274b-7b9c-e053-2995a90aa015
Set id: a1b18e8c-0ad7-38ac-e053-2a95a90a26af
Version: 2
Effective Time: 20200414
 
4 Hands Brewing Company, LLC