Label: ACNE TX MASK- benzoyl peroxide cream

  • 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 August 10, 2010

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  • INDICATIONS & USAGE

    INDICATIONS AND USAGE:

    Formulated as a home treatment for acne-prone skin, this mask gently exfoliates the skin's surface with jojoba beads, allowing the follicular-oxidizing benefits of Benzoyl Peroxide to penetrate and take effect. Plant extracts and MSM are also included to increase healing time and assist in preventing future breakouts.


    DIRECTIONS:

    Apply to cleansed skin using fingertips. Massage gently in circular movements for 1-2 minutes and then allow the product to remain on the skin for an additional 5-10 minutes, depending on skin tolerance and/or sensitivity. Avoid the eye area. Rinse well and follow suggested post-mark home care reigimen. Use this product according the recommendations of your skin care professional. Skip the massage step with Grade 3 and 4 Acne.



  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT:

    Benzoyl Peroxide 2.5%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    Water (Aqua), Butylene Glycol, Jojoba Esters, Glycerin, Sorbitol, Dimethyl Sulfone, Silver, Polysorbate-20, Caprylyl Glycol, Salix alba (Willow) Bark Extract, Carbomer, Triethanolamine, Phenoxyethanol, Extracts of Malva Sylvestris (Mallow), Mentha piperita (Peppermint) Leaf, Primula Veris, Alchemilla vulgaris, Veronica Officinalis, Melissa Officinalis Leaf, Achillea Millefolium, Melia Azadiracta (Neem) Leaf Extract, PEG-60 Almond Glycerides-Nordihydroguaiaretic Acid-Oleanolic Acid, Sodium Benzoate, Disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    DISTRIBUTOR:

    Dermaquest, Inc

    Hayward, CA

    www.dermaquestinc.com


    PRINCIPAL DISPLAY PANEL:

    Principal Display Panel: Acne TX Mask





  • INGREDIENTS AND APPEARANCE
    ACNE TX MASK 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4050-1118.3 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33301/01/2010
    Labeler - Allure Labs, Inc. (926831603)