Label: ADVANCED PURELL- ethyl alcohol liquid

  • 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 August 24, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 70%

  • PURPOSE


    Antimicrobial

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on the skin.

  • 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.

  • DOSAGE & ADMINISTRATION

    Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

  • INACTIVE INGREDIENT

    Water, Isopropyl Alcohol, Isopropyl Alcohol, PEG-12 Dimethicone, Caprylyl Glycol, Glycerin, Propylene Glycol, Isopropyl Myristate, Tocopheryl Acetate, Fragrance.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    ADVANCED  PURELL
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52305-940
    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
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52305-940-10300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/24/2020
    Labeler - Freshorize Ltd (424168503)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.036424534manufacture(52305-940)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470repack(52305-940)
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