Label: ADVANCED ALCOHOL GEL SANITIZER III- sanitizer gel 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 May 12, 2020

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  • PURPOSE

    Antimicrobial

  • ACTIVE INGREDIENT

    Alcohol

  • INDICATIONS & USAGE

    • Hand sanitizer to reduce microorganisms on the skin.
    • Use this product when soap and water are not available.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • WARNINGS

    For external use only. • Avoid contact with eyes. If contact occurs, rinse thoroughly with water. • FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition. • Discontinue use if irritation or redness develops. • If irritation persists for more than 72 hours, consult a physician. • If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • Place enough product on your palm to thoroughly cover your hands.
    • Rub hands together briskly for 30 seconds until dry.

  • INACTIVE INGREDIENT

    Deionized Water, Glycerin, Carbomer, Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    65601-009-88

  • INGREDIENTS AND APPEARANCE
    ADVANCED ALCOHOL GEL SANITIZER III 
    sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-009
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL340 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    5-NORBORNENE-2-METHYLOLACRYLATE (UNII: YR5K75EW22)  
    Product Characteristics
    Colorwhite (transparent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65601-009-88500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/12/2020
    Labeler - Betco Corporation LTD (024492831)
    Registrant - ZHEJIANG RIFESHOW COSMETICS CO.,LTD (560843477)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG RIFESHOW COSMETICS CO.,LTD560843477manufacture(65601-009) , label(65601-009)