Label: HAND CLEANSE WATER MELON SCENT- 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 July 10, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient                   Purpose

    Triclosan 0.2% ................. Antibacterial

  • PURPOSE

    Uses For handwashing to decrease bacteria on the skin.

  • 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.

  • INDICATIONS & USAGE

    Bebelle For Kids

    Gently cleanses & kills germs

    Anti-Bacterial Hand Soap

    Jabon de Manos Antibacterial para Ninos

    Water Melon Scent

  • DOSAGE & ADMINISTRATION

    Directions

    • Pump into hands
    • Lather vigorously for at least 15 seconds
    • rinse and dry thoroughly
  • WARNINGS

    Warnings

    For external use only

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

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, sodium c14-16 olefin sulfonate, sodium laureth sulfate, cocamide MEA, sodium chloride, PEG-150 distearate, glycerin, fragrance, citric acid, disodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, FD&C yellow no.5, FD&C blue no.1

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HAND CLEANSE  WATER MELON SCENT
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50523-085
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50523-085-01221 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/10/2015
    Labeler - Volume Distributors, Inc. (002029544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Volume Distributors, Inc.002029544manufacture(50523-085)
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