Label: NOXZEMA BACTERIA FIGHTING CLEANSER- triclosan 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 October 2, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Triclosan 0.3%

  • Purpose

    Antibacterial

  • 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.
    • 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.

  • 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, Aloe Barbadensis Leaf Juice.

  • Questions?

    1-800-436-4361

  • PRINCIPAL DISPLAY PANEL - 6 oz Tube Label

    PRINCIPAL DISPLAY PANEL - 6 oz Tube Label

  • INGREDIENTS AND APPEARANCE
    NOXZEMA   BACTERIA FIGHTING CLEANSER
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1264
    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:64942-1264-1170 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/02/2012
    Labeler - CONOPCO Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alberto-Culver USA Inc.021679448MANUFACTURE(64942-1264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Laboratories of America LLC013696501manufacture(64942-1264)