Label: ENVIRO E3 RATED SANITIZER- ethanol alcohol liquid

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated April 7, 2020

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  • Active ingredient

    Ethanol Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin that could cause disease.
    • Recommended for repeat use.
  • Warnings

    Flammable. Keep away from fire or flame

    For external use only.

    When using this product

    - Do not use in or near the eyes.
    - In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    - If irritation or rash appears and lasts.

  • Keep out of reach of children. 

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

  • Directions

    • Place enough product in your palm to thoroughly cover your hands. 
    • Rub hands together briskly until dry.
    • No rinsing  required.
    • No towels needed
  • Other information

       Do not store above 110⁰F(43⁰C).

    - May discolor certain fabrics or surfaces.

  • Inactive ingredients

    Water, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Triethanolamine, Acrylates/C10-C30 Alkyl Akrylate, Crosspolymer

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    ENVIRO E3 RATED SANITIZER 
    ethanol alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74693-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74693-001-01800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    2NDC:74693-001-021000000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    3NDC:74693-001-0337854 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/07/2020
    Labeler - IMPERIAL VALLEY DISTRIBUTING, INC (062212557)
    Establishment
    NameAddressID/FEIBusiness Operations
    M CHEM S.A DE C.V.951576034manufacture(74693-001)
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