Label: ANTI-ACNE- 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 January 23, 2008

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  • ACTIVE INGREDIENT


    Active Ingredient:

    Salicylic Acid 2%

  • PURPOSE


    Purpose:

    Acne Treatment Cream

  • INDICATIONS & USAGE

    Use:For the treatment of acne.  Clears up most of the acne blemishes, acne pimples, blackheads or whiteheads.

  • WARNINGS


    Warnings: 

    For external use only.

    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.

  • DOSAGE & ADMINISTRATION


    Directions:

    Cleanse the skin thoroughly before applying the medication.  Cover the entire affected area with a thin layer 1-2 times daily.  Because excessive drying of the skin may occur, start with one application every other day, then gradually increase.  If bothersome dryness or peeling occurs, reduce application to once every other few days.
  • PRECAUTIONS


    Sensitivity test for new user:

    Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated above.

  • INACTIVE INGREDIENT


    Other Ingredients:

    Water, Methyl Gluceth-20, Isopropyl Myristate, Sorbitan Stearate, Cetyl Alcohol, Alcohol Denat, Triethanolamine, Caprylic/Capric Triglyceride, Dimethicone,
    Sodium Polyacrylate, Ceteareth-20, Butylene Glycol, Ethylhexyl Stearate, Capryloyl Glycine, Sarcosine, Cinnamomum Zeylanicum Bark Extract, Mel (Honey Extract), Trideceth-6, Retinyl Palmitate, Tocopheryl Acetate, Hydroxyethylcellulose, Arnica Montana Flower Extract, Xanthan Gum, Disodium EDTA, Diazolidinyl Urea, Iodopropynyl Butylcarbamate.

  • PRINCIPAL DISPLAY PANEL

    Image of carton for Anti Acne Lotion

  • INGREDIENTS AND APPEARANCE
    ANTI-ACNE 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-312
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59735-312-561 in 1 CARTON
    156.8 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33301/23/2008
    Labeler - Biocosmetics Research Labs (078870292)
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