Label: SOPURE- denatured ethanol liquid

  • NDC Code(s): 80773-001-01, 80773-001-02, 80773-001-03, 80773-001-04, view more
    80773-001-05
  • Packager: EnviroServe Chemicals & Cleaners Ltd
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 30, 2023

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  • 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

  • INGREDIENTS AND APPEARANCE
    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 DrugM00302/07/2020
    Labeler - EnviroServe Chemicals & Cleaners Ltd (243690711)
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