Label: MEGAFRESH ANTIBACTERIAL DEODORANT- triclocarban soap 

  • Label RSS
  • NDC Code(s): 54157-101-01, 54157-101-02, 54157-101-03, 54157-101-04, view more
    54157-101-05, 54157-101-06, 54157-101-07, 54157-101-08, 54157-101-09, 54157-101-10, 54157-101-11, 54157-101-12
  • Packager: American Amenities, Inc.
  • 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 03/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: Triclocarban (0.3%)

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  • PURPOSE

    Purpose: Antibacterial

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  • INDICATIONS & USAGE

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

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  • WARNINGS

    For external use only. Keep out of reach of children

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  • 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.

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  • ASK DOCTOR

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

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  • DOSAGE & ADMINISTRATION

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

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  • INACTIVE INGREDIENT

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

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  • INGREDIENTS AND APPEARANCE
    MEGAFRESH ANTIBACTERIAL DEODORANT 
    triclocarban soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54157-101
    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
    WATER  
    PALM OIL  
    PALM KERNEL OIL  
    SODIUM CHLORIDE  
    TITANIUM DIOXIDE  
    EDETIC ACID  
    Product Characteristics
    Color white Score no score
    Shape RECTANGLE Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54157-101-01 10 g in 1 PACKAGE
    2 NDC:54157-101-02 13 g in 1 PACKAGE
    3 NDC:54157-101-03 20 g in 1 PACKAGE
    4 NDC:54157-101-04 25 g in 1 PACKAGE
    5 NDC:54157-101-05 30 g in 1 PACKAGE
    6 NDC:54157-101-06 35 g in 1 PACKAGE
    7 NDC:54157-101-07 42.5 g in 1 PACKAGE
    8 NDC:54157-101-08 54 g in 1 PACKAGE
    9 NDC:54157-101-09 60 g in 1 PACKAGE
    10 NDC:54157-101-10 70 g in 1 PACKAGE
    11 NDC:54157-101-11 75 g in 1 PACKAGE
    12 NDC:54157-101-12 85 g in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/04/2013
    Labeler - American Amenities, Inc. (181454026)
    Registrant - American Amenities, Inc. (181454026)
    Establishment
    Name Address ID/FEI Business Operations
    American Amenities, Inc. 181454026 manufacture(54157-101)
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