SOPURE 80% ETHANOL SANITIZING WIPES- 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 80% Ethanol Wipes

Drug Facts

Active ingredient

Ethanol 80%

Purpose

Medicated Skin Cleanser Kills harmful bacteria/germs

Uses

Hand Sanitizing wipes Kills harmful bacteria/germs.

Warnings

For external use only.

Flammable keep away from fire or flame, heat, spark, electrical

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).
If swallowed, call a poison control center or get medical help right away.

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • do not get in eyes

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other information

  • keep Packet tightly closed and stored at room temperature
  • hold away from face when opening

Inactive ingredient

Water, glycerin, hydrogen peroxide, alpha tocopherol acetate

Questions or comments?

nfo@sopureproductsinc.com

Package Labeling:

SoPure 80 Wipes

Label

SoPure 100 Wipes

Label

SoPure 120 wipes

Label

SoPure 160 Wipes

Label

SOPURE 80% ETHANOL SANITIZING WIPES 
ethanol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80773-003
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)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80773-003-0080 in 1 PACKET06/16/2023
14.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:80773-003-01100 in 1 PACKET06/16/2023
24.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:80773-003-02120 in 1 PACKET06/16/2023
34.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC:80773-003-03160 in 1 PACKET06/16/2023
44.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/16/2023
Labeler - EnviroServe Chemicals & Cleaners Ltd. (243690711)
Registrant - EnviroServe Chemicals & Cleaners Ltd. (243690711)
Establishment
NameAddressID/FEIBusiness Operations
EnviroServe Chemicals & Cleaners Ltd243690711manufacture(80773-003)

Revised: 6/2023
Document Id: fe41032f-0f5d-faf2-e053-6394a90a2b05
Set id: fe410150-69e2-7348-e053-6394a90a1c47
Version: 1
Effective Time: 20230616
 
EnviroServe Chemicals & Cleaners Ltd.