Label: ANTI-BACTERIAL BUBBLE GUM HAND- triclosan soap

  • 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 November 30, 2012

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  • ACTIVE INGREDIENT

    Active ingredient:
    Triclosan 0.3%
  • PURPOSE

    Purpose
    Antimicrobial
  • INDICATIONS & USAGE

    KILLS MORE THAN 99.99% OF COMMON GEMS
  • WARNINGS

    FOR EXTERNAL USE ONLY. DO NOT USE IN THE EYES.
  • STOP USE

    DISCONTINUE USE IF IRRITATION AND REDNESS DEVELOP. IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. CHILDREN CAN ONLY USE THIS PRODUCT WITH ADULT SUPERVISION.
  • DOSAGE & ADMINISTRATION

    DIRECTIONS:
    WET HANDS.APPLY PALMFUL TO HANDS. SCRUB THOROUGHLY. RINISE. RECOMMENDED FOR REPEATED USE.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:Water, Sodium Alkyl Ether Sulphate, Ammonium Lauryl Sulphate, Cocamidopropyl Betaine, Cocamide DEA, Disodium Laureth Sulfosuccinate, Sodium Chloride, Glycol Distearate, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Citric Acid, Disodium EDTA, FD&C Red NO. 33

  • PRINCIPAL DISPLAY PANEL

    image of bottle hangtag
  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL BUBBLE GUM HAND  
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53603-2014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C12-15 PARETH-3 SULFATE (UNII: 19Q4RW8UWP)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53603-2014-8236.6 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/30/2012
    Labeler - BB17, LLC (828378294)
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