Label: CORALITE ULTRA ANTIBACTERIAL DEODORANT - triclocarban soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/14

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  • ACTIVE INGREDIENT

    Active ingredient                                                            Purpose

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

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  • PURPOSE

    Uses

    • for washing to decrease bacteria on the skin
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  • WARNINGS

    Warnings For external use only.

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  • WHEN USING

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

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  • STOP USE

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

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  • 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.

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  • INDICATIONS & USAGE

    Directions

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

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  • DOSAGE & ADMINISTRATION

    Distributed By:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    CORALITE ULTRA ANTIBACTERIAL DEODORANT  
    triclocarban soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65923-807
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOCARBAN (TRICLOCARBAN) TRICLOCARBAN 0.3 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM COCOATE  
    SODIUM PALMATE  
    WATER  
    GLYCERIN  
    SODIUM CHLORIDE  
    PALM ACID  
    PEG-6 METHYL ETHER  
    SORBITOL  
    PENTASODIUM PENTETATE  
    FD&C YELLOW NO. 5  
    D&C YELLOW NO. 8  
    FD&C RED NO. 4  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65923-807-35 100 g in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 07/30/2014
    Labeler - United Exchange Corp (840130579)
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