Label: BBHOME RINSE-FREE HAND SANITIZER- hand sanitizer 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 23, 2020

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  • DOSAGE & ADMINISTRATION

    Inflammable and store in a cool place;

  • INACTIVE INGREDIENT

    Water

    Ethylhexylglycerol

    Triethanolamine

    glycerin

    Phenoxyethanol

    Acrylic

    LONICERA JAPONICA

    CHRYSANTHEMUM INDICUM

  • INDICATIONS & USAGE

    Squeeze out an appropriate portion of the gel,apply it directly onto the hands and rub for a few seconds.

  • ACTIVE INGREDIENT

    Ethanol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • PURPOSE

    Disinfection
    Sterilization

  • WARNINGS

    1.External Use Only;

    2.place it where children cannot reach;

    3. Inflammable and store ina cool place;

    4. Use with care for alcohol allergic persons.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BBHOME RINSE-FREE HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52809-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL85.5 mL  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L)  
    2,2-DINITROPROPYL ACRYLATE (UNII: W5F83UPW7D)  
    Product Characteristics
    Color    Score    
    ShapeBULLETSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52809-001-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/23/2020
    Labeler - Leads Beauty (Nanjing) Co., Ltd. (528096117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Leads Beauty (Nanjing) Co., Ltd.528096117manufacture(52809-001)