Label: IMAGE ESSENTIALS GOLD- 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 30, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient-----------------------------------------------------Triclocarban 0.30%

  • PURPOSE

    For washing to decrease bacteria on the skin.

  • WARNINGS

    Warnings For external use only

    when using this product

    • Avoid contact with eyes. In case of eye contact, flush with water.
    • Stop usee and ask a doctor if irritation and redness develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of childern.  if swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • Wet bar with water
    • Lather vigorously and watsh skin
    • rinse and dry thoroughly
  • INACTIVE INGREDIENT

    Other ingredients: soap (sodium tallowate, sodium cocoate, sodium palmate types), water, glycerin, fragrance, sodium chloride, palm acid or tallowate acid, PEG-6 methyl ether, sorbitol, tetrasodium etidronate, BHT, pentasodium pentetate, FD&C yellow no. 5, D&C yellow no. 8, FD&C red no. 4

  • DOSAGE & ADMINISTRATION

    Distributed by

    K Mart Corporation

    Hoffman Estate, IL 60179

    Shop kmart.com

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    IMAGE ESSENTIALS GOLD 
    triclocarban soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-731
    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 TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PALM ACID (UNII: B6G0Y5Z616)  
    PEG-6 METHYL ETHER (UNII: WXH089JZ5E)  
    SORBITOL (UNII: 506T60A25R)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-731-121 in 1 CARTON
    1113 g in 1 CELLO PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/30/2014
    Labeler - Kmart Corporation (008965873)
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