Label: CLEAR CELL MEDICATED ACNE- benzoyl peroxide, salicylic acid lotion

  • 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 July 1, 2010

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

  • ACTIVE INGREDIENT

    Active Ingredients:

    Benzoyl Peroxide 5.00%

    Salicylic Acid 3.00%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Aqua (Water), Aloe barbadensis leaf extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Sorbitan Olivate, PEG-7 Glyceryl Cocoate, Extracts of Malva sylvestris (Mallow), Mentha piperita (Peppermint) leaf, Primula veris, Alchemilla vulgaris, Veronica officinalis, Melissa officinalis leaf, Achillea millefolium, Tocopheryl acetate (Vitamin E), Camellia sinensis leaf extract, Arnica montana flower extract, Chamomilla recutita flower extract, Aesculus hippocastanum (Horse Chestnut) extract, Melia azadirachta leaf extract, Melaleuca alternifolia leaf oil, Mentha virdis (Spearmint) oil, Eucalyptus globulus leaf oil, Disodium  EDTA.

  • PRINCIPAL DISPLAY PANEL

    Information on the back of the container:

    (Claims)

    A daily oil-free lotion to control over production of oil and bacteria. An anti-oxidant blend improves hydration and health of acne skin. Natural skin lighteners diminish redness of acne lesions.

    Paraben-free


    DIRECTIONS:

    Apply to cleasnsed skin every morning and evening. May be used as spot treatment daily to diminish acne lesions.


    INDICATIONS:

    Acne and acne prone skin.


    DISTRIBUTOR:

    Image International

    Palm Beach, FL 33411 USA

    www.imageskincare.com


    Image of the product:

    CLEAR CELL   Medicated Acne Lotion

    Image of the product




  • INGREDIENTS AND APPEARANCE
    CLEAR CELL MEDICATED ACNE 
    benzoyl peroxide, salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID30 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4035-150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33301/01/2010
    Labeler - Allure Labs, Inc. (926831603)