Label: CORALITE ULTRA ANTIBACTERIAL DEODORANT- triclocarban 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 July 30, 2014

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  • ACTIVE INGREDIENT

    Active ingredient                                                            Purpose

    Triclocarban 0.3%....................................................Antibacterial

  • PURPOSE

    Uses

    • for 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.

  • INDICATIONS & USAGE

    Directions

    • wet bar with water
    • lather vigorously and wash skin
    • rinse and dry thoroughly
  • INACTIVE INGREDIENT

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

  • DOSAGE & ADMINISTRATION

    Distributed By:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CORALITE ULTRA ANTIBACTERIAL DEODORANT  
    triclocarban soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-807
    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)  
    PALM ACID (UNII: B6G0Y5Z616)  
    PEG-6 METHYL ETHER (UNII: WXH089JZ5E)  
    SORBITOL (UNII: 506T60A25R)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C YELLOW NO. 8 (UNII: 93X55PE38X)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-807-35100 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/30/2014
    Labeler - United Exchange Corp (840130579)
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