Label: NOXZEMA- salicylic acid cloth

  • 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 17, 2009

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 2%

  • Purpose

    Acne treatment

  • Uses

    • treats acne
    • dries up acne pimples
    • helps prevent new acne pimples
  • Warnings

    • For external use only.
    • Flammable - keep away from extreme heat or open flame

    When using this product

    • Avoid contact with eyes, lips, and mouth. If contact with eyes occurs, rinse eyes thoroughly with water.
    • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases.

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

    • Cleanse the skin thoroughly before applying medication.
    • Cover the entire affected area with a thin layer 1 to 3 times daily.
    • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Inactive ingredients

    Alcohol Denat., Water (Aqua, Eau), PEG-4, PPG-11 Stearyl Ether, Fragrance (Parfum), Eugenol, Linalool, Limonene, Geraniol, Benzyl Benzoate, Disodium EDTA, Cinnamal, Citral

  • Questions?

    1-800-436-4361

  • SPL UNCLASSIFIED SECTION

    Alberto Culver USA, Inc. Melrose Park, IL 60160

  • PRINCIPAL DISPLAY PANEL - 90 Pad Bottle Label

    NOXZEMA®

    NEW
    LOOK

    TRIPLE CLEAN
    Anti-Blemish Pads

    Clears & protects leaving
    skin soft & smooth

    with Medicated Salicylic Acid

    90 PADS (2.25 in/5.7 cm diameter)

    PRINCIPAL DISPLAY PANEL - 90 Pad Bottle Label
  • INGREDIENTS AND APPEARANCE
    NOXZEMA   TRIPLE CLEAN
    salicylic acid cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12488-1100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Alcohol (UNII: 3K9958V90M)  
    Menthol (UNII: L7T10EIP3A)  
    Camphor (UNII: 5TJD82A1ET)  
    Eucalyptus Globulus Leaf (UNII: S546YLW6E6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12488-1100-190 in 1 BOTTLE
    10.0284 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D06/01/2009
    Labeler - Alberto-Culver USA Inc. (021679448)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alberto-Culver USA Inc.021679448ANALYSIS, MANUFACTURE