Label: NOXZEMA- triclosan soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 December 21, 2009

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Triclosan 0.3%

  • Purpose

    Anti-Bacterial

  • Uses

    For cleansing to decrease bacteria on skin

  • 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. If signs of irritation or rash appear, discontinue use. 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.

  • 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.
  • 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, Tetrasodium Etidronate, Linalool, Iodopropynyl Butylcarbamate, Aloe Barbadensis Leaf Juice

  • Questions?

    1-800-436-4361

  • SPL UNCLASSIFIED SECTION

    Alberto Culver USA, Inc.
    Melrose Park, IL 60160

  • PRINCIPAL DISPLAY PANEL - 6 oz Tube Label

    NOXZEMA®

    NEW
    LOOK

    TRIPLE CLEAN
    Anti-Bacterial
    Lathering Cleanser

    Clears blemishes and fights
    bacteria with a purifying clean

    Oil-Free
    with Medicated Anti-Bacterial Triclosan

    Net Wt 6 OZ (170g)

    PRINCIPAL DISPLAY PANEL - 6 oz Tube Label
  • INGREDIENTS AND APPEARANCE
    NOXZEMA   TRIPLE CLEAN
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12488-1000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan0.003 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Glycerin (UNII: PDC6A3C0OX)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Palmitic Acid (UNII: 2V16EO95H1)  
    Myristic Acid (UNII: 0I3V7S25AW)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Lauric Acid (UNII: 1160N9NU9U)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12488-1000-1170 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33306/01/2009
    Labeler - Alberto-Culver USA Inc. (021679448)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alberto-Culver USA Inc.021679448ANALYSIS, MANUFACTURE
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