Label: WATERLESS ANTIBACTERIA HAND SANITIZER- ethanol liquid

  • Category: HUMAN OTC DRUG LABEL

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 20, 2020

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  • Active ingredient

    Ethanol 75%

  • Purpose

    disinfecting , sterilization

  • Uses

    hand washing

  • Warnings

    For external use only
    Do not use■Do not use it in the eyes or inner ears
    ■Prohibited use for ethanol allergy|
    When using this product
    s Avoid open flames
    ■Sealed, and stored in a cool and dark place
    Stop use and ask a doctor if too much skin rritation
    or sensitivity develops or increases

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get
    medical help or contact a Poison Control Center
    right away.

  • Directions

    n Take a proper amount of liquid and rub hands until dry
    ■Germicidal Efficacy: Klling intestinal pathogenic
    bacteria, pyogenic cocci and pathogenic yeast fungi
    ■Uses: Suitable for hand disinfection in medical
    and health institutions, pharmaceutical industry,
    food industry, hotels, schools, waiting rooms,
    and other public places, as well as disinfection
    before surgery. It is waterless and not sticky.

  • INACTIVE INGREDIENT

    Melaleuca alternifolia (tea tree essential oil) ，poly(acrylic acid)，Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    WATERLESS ANTIBACTERIA HAND SANITIZER 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70876-003
    Route of AdministrationTOPICAL
    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)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70876-003-011 in 1 BOX04/20/2020
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/20/2020
    Labeler - Fujian Meigulin Bio-Technique Co., Ltd. (529340399)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fujian Meigulin Bio-Technique Co., Ltd.529340399manufacture(70876-003)
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