SOPURE- denatured ethanol cloth 
EnviroServe Chemicals & Cleaners Ltd

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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SOPURE Sanitizing Wipes

Active Ingredient

Ethanol USP 80%v/v

Purpose

Medicated Skin Cleanser Kills harmful bacteria/germs

Warnings

Uses

Hand Sanitizing wipes Kills harmful bacteria/germs.

Directions

Use as need on basis. Wipe your hands to help prevent spread of bacteria.

Keep out of reach of Children

Do not use on children / infants less than 2 years of age (unless directed by a doctor or physician.)

Inactive Ingredients

Water, glycerin, hydrogen peroxide, alpha tocopherol acetate

Product Label

Wipes 80wipes 100wipes 120Wipes 160

SOPURE 
denatured ethanol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80773-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80773-002-01100 in 1 POUCH; Type 0: Not a Combination Product11/23/2021
2NDC:80773-002-0280 in 1 POUCH; Type 0: Not a Combination Product11/23/2021
3NDC:80773-002-03120 in 1 POUCH; Type 0: Not a Combination Product11/23/2021
4NDC:80773-002-04160 in 1 POUCH; Type 0: Not a Combination Product11/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/23/2021
Labeler - EnviroServe Chemicals & Cleaners Ltd (243690711)

Revised: 11/2021
Document Id: d17cad69-6078-1101-e053-2a95a90a1b55
Set id: d17cad69-6077-1101-e053-2a95a90a1b55
Version: 1
Effective Time: 20211123
 
EnviroServe Chemicals & Cleaners Ltd