ALCOHOL ANTISPETIC 62% TOPICAL SOLUTION HAND SANITIZER- alcohol solution 
Wink Naturals, 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

Directions

Other information

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)

Hand Santiizer v1

ALCOHOL ANTISPETIC 62% TOPICAL SOLUTION HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77041-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
WATER (UNII: 059QF0KO0R)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77041-002-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/26/2020
Labeler - Wink Naturals, LLC (080534823)
Establishment
NameAddressID/FEIBusiness Operations
Wasatch Product Development, LLC962452533manufacture(77041-002)

Revised: 5/2020
Document Id: a69552fd-7668-dc67-e053-2995a90a83e2
Set id: a6958ee2-841f-f777-e053-2a95a90ab78e
Version: 1
Effective Time: 20200526
 
Wink Naturals, LLC