Label: NOXZEMA BACTERIA FIGHTING CLEANSER- triclosan soap

  • NDC Code(s): 64942-1264-1
  • Packager: CONOPCO Inc. d/b/a Unilever
  • 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 10/12

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Triclosan 0.3%

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  • Purpose

    Antibacterial

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  • Uses

    For cleansing to decrease bacteria on skin

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  • Warnings

    • For external use only. Do not use on infants under 6 months of age.

    When using this product

    • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
    • Discontinue use if signs of irritation or rash appear.

    Stop use and ask a doctor if irritation or rash persists or is excessive.

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

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  • Directions

    • Wet face. Dispense product into hands.
    • Add water and work into a lather, adding more water if necessary.
    • Massage gently onto face and neck.
    • Rinse thoroughly with water.
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  • Inactive ingredients

    Water (Aqua, Eau), Glycerin, Myristic Acid, Stearic Acid, Palmitic Acid, Sodium Lauroyl Sarcosinate, Lauric Acid, Potassium Hydroxide, Polyquaternium-10, DMDM Hydantoin, Fragrance (Parfum), Pentasodium Pentetate, Aloe Barbadensis Leaf Juice.

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  • Questions?

    1-800-436-4361

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  • PRINCIPAL DISPLAY PANEL - 6 oz Tube Label
  • INGREDIENTS AND APPEARANCE
    NOXZEMA   BACTERIA FIGHTING CLEANSER
    triclosan soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64942-1264
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Triclosan (Triclosan) Triclosan 0.003 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Aloe Vera Leaf  
    Glycerin  
    Iodopropynyl Butylcarbamate  
    Palmitic Acid  
    Myristic Acid  
    Stearic Acid  
    Lauric Acid  
    Potassium Hydroxide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64942-1264-1 170 g in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 10/02/2012
    Labeler - CONOPCO Inc. d/b/a Unilever (001375088)
    Establishment
    Name Address ID/FEI Business Operations
    Alberto-Culver USA Inc. 021679448 MANUFACTURE(64942-1264)
    Establishment
    Name Address ID/FEI Business Operations
    Cosmetic Laboratories of America LLC 013696501 manufacture(64942-1264)
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