Label: ALCOHOL DISINFECTANTSPRAY- alcohol disinfectant 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 May 15, 2020

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  • DOSAGE & ADMINISTRATION

    store in a cool, dry and ventilated place.

  • INACTIVE INGREDIENT

    water

  • INDICATIONS & USAGE

    1.Skin disinfectant:Spray the disinfectant evenly on the skin surface for one minute.

    2.objects surface disinfection:evenly Spray or wipe the disinfectant on the Surface of the objects for three minutes.

  • ACTIVE INGREDIENT

    ALCOHOL

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization

  • WARNINGS

    1.For external use only, not for oral use; if alergic to ethanol, use with caution; keep out of reach of children.

    2.Flammable, away from fire source; keep in dark place; store in a cool, dry and ventilated place.
    3.Not suitable for the disinfection of the surface of fat-soluble objects.
    4.To avoid starting a fire, not applicable for large area disinfection of objects surface.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL DISINFECTANTSPRAY 
    alcohol disinfectant liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54522-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code NENGLIANGSHEN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54522-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/15/2020
    Labeler - Shandong Fulaichun Biochemical Industry Co., Ltd (545225568)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Fulaichun Biochemical Industry Co., Ltd545225568manufacture(54522-001)
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