Hand Sanitizer by William Price Distilling Company

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by William Price Distilling Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
William Price Distilling Company

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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Active Ingredient(s):

Alcohol 80% v/v. Purpose: Antiseptic

Antiseptic, Hand Sanitizer

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.

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.

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

ethyl hydroxyethyl cellulose, glycerin, hydrogen peroxide, purified water USP

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76920-002
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
HYDROXYETHYL ETHYLCELLULOSE (UNII: ZDN57Z154K)	0.667 g  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: 76920-002-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020
2	NDC: 76920-002-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020
3	NDC: 76920-002-03	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/12/2020	03/31/2022

Labeler - William Price Distilling Company (095291776)

Establishment
Name	Address	ID/FEI	Business Operations
William Price Distilling Company		095291776	manufacture(76920-002)

Revised: 4/2022

Document Id: dc2911d7-36ee-d39d-e053-2a95a90a04bc

34390-5

Set id: a70d4252-a2ea-3612-e053-2995a90a5b03

Version: 2

Effective Time: 20220408