Label: BEBELLE FOR KIDS ANTIBACTERIAL HAND- triclosan soap

  • 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 September 4, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient

    Triclosan 0.2%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses:

    for hand washing to decrease bacteria on the skin.

  • WARNINGS

    Warnings for external use only.

  • WHEN USING

    When using this product avoid contact with eyes. In case of eye contact, flush with water.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develops.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    pump into hands

    lather vigorously for at least 15 seconds

    rinse and dry thoroughly.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water (aqua), ammonium lauryl sulfate, ammonium chloride, lauramide DEA, DMDM hydantoin, fragrance, citric acid, tatrasodium EDTA, FD and C Red No. 40

  • PRINCIPAL DISPLAY PANEL

    Bebelle

    For Kids

    Gently cleanses and kills germs

    Antibacterial Hand Soap

    Strawberry

    Distributed by

    Bebelle Products

    Vernon, CA 90058

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    Bebelle for Kids Hand Soap

  • INGREDIENTS AND APPEARANCE
    BEBELLE FOR KIDS ANTIBACTERIAL HAND 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50523-546
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50523-546-75221 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 finalpart333E12/22/2010
    Labeler - Volume Distributors, Inc. (002029544)
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