Label: ALCOHOL DISINFECTANT(DISPOSABLE HAND SANITIZER)- alcohol disinfection 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 April 15, 2020

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  • DOSAGE & ADMINISTRATION

    keep it out of reach of children. Store between 0°C-43 C .

  • INACTIVE INGREDIENT

    Purified Water

    Triethanolamine

    Carbomer.

  • INDICATIONS & USAGE

    Take an appropriate amount of this product on the palm of your hand, rub your whole hands with it until it is dry, no washing required

  • ACTIVE INGREDIENT

    Ethanol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • PURPOSE

    Disinfection
    Sterilization

  • WARNINGS

    1.This product is for external use only.
    2. Prohibited use for those allergic to alcohol. Prohibited use on the eyes.
    3.Please keep it out of reach of children.Store between 0°C-43 C.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL DISINFECTANT(DISPOSABLE HAND SANITIZER) 
    alcohol disinfection gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54644-002
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL375 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54644-002-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/08/2020
    Labeler - Guangdong Jiasheng Environmental Protection High-Tech Material Co.,Ltd. (546441202)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Jiasheng Environmental Protection High-Tech Material Co.,Ltd.546441202manufacture(54644-002)
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