Label: ACNE AND BLEMISH TARGET- salicylic acid gel

  • 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 February 13, 2003

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  • ACTIVE INGREDIENT


    Active Ingredient

    Salicylic Acid 2%

  • PURPOSE

    Purpose

    Acne Treatment Gel
  • 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 the 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 one to three times daily. Because excessive drying of the skin may occur start with one application daily, then gradually increase to two or three 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.

  • PRECAUTIONS


    Sensitivity test for new user:

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

  • INACTIVE INGREDIENT


    Inactive Ingredients:

    Water (Aqua), Alcohol Denat., Hamamelis Virginiana (Witch Hazel) Extract, Propylene Glycol, Carbomer, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Salix Alba (Willow) Bark Extract, Lonicera Caprifolium (Honeysuckle) Flower Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Triethanolamine, Sodium Hydroxide.

  • PRINCIPAL DISPLAY PANEL

    image of carton acne blemish gel

  • INGREDIENTS AND APPEARANCE
    ACNE AND BLEMISH TARGET 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-302
    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:59735-302-151 in 1 BOX
    115 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33302/13/2003
    Labeler - Biocosmetics Research Labs (078870292)