NOXZEMA (TRICLOSAN) SOAP [ALBERTO-CULVER USA INC.]

NOXZEMA (TRICLOSAN) SOAP [ALBERTO-CULVER USA INC.]
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NDC 12488-1000-1
Set ID 6fc04f77-4c47-43b3-98f2-d16e686feb09
Category HUMAN OTC DRUG LABEL
Packager Alberto-Culver USA Inc.
Generic Name
Product Class
Product Number
Application Number PART333
  • 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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