Label: MEGAFRESH 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 May 30, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient: Triclocarban (0.3%)

  • PURPOSE

    Purpose: Antibacterial

  • INDICATIONS & USAGE

    Uses: For hand washing to decrease bacteria on the skin. Recommended for repeated use.

  • WARNINGS

    For external use only. Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    Children should use only this product under adults supervision. Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Avoid contact with broken skin.

  • ASK DOCTOR

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

  • DOSAGE & ADMINISTRATION

    Lather on wet skin and rinse well. Recommended for repeated use

  • INACTIVE INGREDIENT

    Palm Oil, Water, Palm Kernel Oil, Sodium Chloride, Titanium Dioxide, Edetic Acid, Fragrance

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    MEGAFRESH ANTIBACTERIAL DEODORANT 
    triclocarban soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54157-101
    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
    WATER (UNII: 059QF0KO0R)  
    PALM OIL (UNII: 5QUO05548Z)  
    PALM KERNEL OIL (UNII: B0S90M0233)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54157-101-0110 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:54157-101-0213 g in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:54157-101-0320 g in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:54157-101-0425 g in 1 PACKAGE; Type 0: Not a Combination Product
    5NDC:54157-101-0530 g in 1 PACKAGE; Type 0: Not a Combination Product
    6NDC:54157-101-0635 g in 1 PACKAGE; Type 0: Not a Combination Product
    7NDC:54157-101-0742.5 g in 1 PACKAGE; Type 0: Not a Combination Product
    8NDC:54157-101-0854 g in 1 PACKAGE; Type 0: Not a Combination Product
    9NDC:54157-101-0960 g in 1 PACKAGE; Type 0: Not a Combination Product
    10NDC:54157-101-1070 g in 1 PACKAGE; Type 0: Not a Combination Product
    11NDC:54157-101-1175 g in 1 PACKAGE; Type 0: Not a Combination Product
    12NDC:54157-101-1285 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/04/2013
    Labeler - American Amenities, Inc. (181454026)
    Registrant - American Amenities, Inc. (181454026)
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