Label: ANTIBACTERIAL GOLDEN BURST- triclocarban 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 15, 2015

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  • Active Ingredient

    Triclocarban 0.30%

  • Purpose

    Antibacterial

  • Uses

    • Helps reduce bacteria on the skin that could cause disease.
    • Recommended for repeated use
  • Warnings

    For external use only

  • When using this product:

    do not use in or near the eyes. In case of eye contact, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if:

    irritation and redness develops and lasts more than 72 hours.

  • Keeps out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet bar with water
    • Lather vigorously and wash skin
    • Rinse and dry thoroughly
  • Other Information

    • Store below 110° F (43° C)
    • May discolor certain fabrics or surfaces
  • Inactive Ingredients

    Sodium Cocoate, Sodium Palmate, Water, Glycerin, Sodium Chloride, Titanium Dioxide, BHT, Fragrance, FD&C Yellow #5

  • Package Display

    label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL GOLDEN BURST 
    triclocarban soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y) TRICLOCARBAN0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-120-033 in 1 PACKET08/03/2015
    190 g in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2015
    Labeler - International Wholesale, Inc. (161872676)
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