Alcohol Antispetic 62% Topical Solution Hand Sanitizer

Alcohol Antispetic 62% Topical Solution Hand Sanitizer by

Drug Labeling and Warnings

Alcohol Antispetic 62% Topical Solution Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Wasatch Product Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL ANTISPETIC 62% TOPICAL SOLUTION HAND SANITIZER- alcohol solution 
Wasatch Product Development, 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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Alcohol Antispetic 62% Topical Solution Hand Sanitizer

Active Ingredient Purpose

Alcohol 62% v/v. Antiseptic

Purpose

Antiseptic

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

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

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.

Do not use

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

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

Water, Fragrance, Carbomer, PEG-40 Hydrogenated Castor Oil, Chlorphenesin, Aminomethyl Propanol

Package Label - Principal Display Panel

Wink Naturals

Alcohol Antiseptic 62% Topical Solution

Hand Sanitizer

Non-sterile

4 FL OZ (118 mL)

ALCOHOL ANTISPETIC 62% TOPICAL SOLUTION HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44717-063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)
CHLORPHENESIN (UNII: I670DAL4SZ)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44717-063-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020	09/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/26/2020	09/29/2022

Labeler - Wasatch Product Development, LLC (962452533)

Establishment
Name	Address	ID/FEI	Business Operations
Wasatch Product Development, LLC		962452533	manufacture(44717-063)

Revised: 11/2022

Document Id: eeb9aea4-4511-c762-e053-2a95a90abaf1

34390-5

Set id: 178c5f6b-0165-4317-9378-abfd4750b858

Version: 2

Effective Time: 20221130