SOPURE- denatured ethanol liquid 
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

Active Ingredient

Denatured Ethanol 80%v/v

Purpose

Medicated Skin Cleanser Kills harmful bacteria/germs

Warnings

  • Avoid contact with eyes. In case of contact, rinse eyes thoroughly with water. 
  • If irritation develops, consult a doctor. 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). 
  • Ifswallowed, call a poison control center or get medical help right away. 
  • Keep away from open flame and sources of heat.

Uses

Hand Sanitizer / Medicated Skin Cleanser Kills harmful bacteria/germs.

Directions

  • Spray product on dry hands, rub for 30 seconds. 
  • This product should be sued as part of the daily cleansing routine.

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, natural glycerol / glycerin, emollients (contains tocopherol, vitamin E, may contain aloe babadensis, fragrances, DE&; F color additives.)

Product Label

image description

SoPure 20 ml

Front Label

Back Label

SOPURE 
denatured ethanol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80773-001
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80773-001-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product02/07/2020
2NDC:80773-001-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product02/07/2020
3NDC:80773-001-03946 mL in 1 BOTTLE; Type 0: Not a Combination Product02/07/2020
4NDC:80773-001-044000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/07/2020
5NDC:80773-001-0520 mL in 1 POUCH; Type 0: Not a Combination Product06/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/07/2020
Labeler - EnviroServe Chemicals & Cleaners Ltd (243690711)

Revised: 9/2023
Document Id: 069369e0-7e06-793a-e063-6394a90a1352
Set id: a3fd9f59-a6ee-4eef-a3e1-63fd534a6142
Version: 6
Effective Time: 20230930
 
EnviroServe Chemicals & Cleaners Ltd