Label: ZEPOL- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 June 22, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 65% v/v. Purpose: Antiseptic

  • PURPOSE

    Antisptic, Hand Sanitizer

  • WARNINGS

    Flammable. Keep awy from fire or flame. For external use.

  • DO NOT USE

    In children less than 2 months of age

    On open skin wounds

  • WHEN USING

    Do not use in eyes. In case of contact with eyes, rinse with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help promptly.

  • DOSAGE & ADMINISTRATION

    Place enough product on hands to cover all surface. Rub hands together until dry.

    Supervise children under 6 years of age when using this product to avoid swallowing

  • STORAGE AND HANDLING

    Store between 15-30C (59-89F)

  • INDICATIONS & USAGE

    For handwashing to decrease bacteria for the skin.

  • INACTIVE INGREDIENT

    Water, carbomer, isopropyl alcohol, triethanolamine

  • PRINCIPAL DISPLAY PANEL

    3.785 L Label3.785L NDC 79198-656-01

  • INGREDIENTS AND APPEARANCE
    ZEPOL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79198-656
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FENOPROP TRIETHANOLAMINE (UNII: 2F3CU8K84U)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79198-656-013785 mL in 1 JUG; Type 0: Not a Combination Product06/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/22/2020
    Labeler - DILE ENTERPRISES LLC (117555202)
    Establishment
    NameAddressID/FEIBusiness Operations
    DILE ENTERPRISE LLC117555202manufacture(79198-656)
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