Label: CLEARSKIN BLEMISH CLEARING OVERNIGHT TREATMENT- salicylic acid cream

  • 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 1, 2019

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  • ACTIVE INGREDIENT

    Active ingredient     

    Salicylic Acid 2.0%.......................

                            Purpose
    ........................Acne Treatment

  • INDICATIONS & USAGE

    Uses

    • for the treatment of acne
  • WARNINGS

    Warnings
    For external use only

    When using this product

    • avoid contact with eyes. If product contacts eyes, rinse thoroughly with water.
    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical medication at a time unless directed by a Health Care Practitioner.

    Stop Use and ask a Health Care practitioner if:

    • Rash or irritation develops or increases.

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    • Cleanse the skin thoroughly before applying this product.
    • 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 health care practitioner.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

  • INACTIVE INGREDIENT

    Inactive Ingredients: WATER/EAU, GLYCERIN, BUTYLENE GLYCOL, DIMETHICONE, ETHYLHEXYL ISONONANOATE, BEHENYL ALCOHOL, CETEARYL ALCOHOL, PPG-5-CETETH-20, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PENTAERYTHRITYL TETRAETHYLHEXANOATE, THIODIPROPIONIC ACID, ISOHEXADECANE, STEARETH-2, AMMONIUM HYDROXIDE, PEG-100 STEARATE, DIMETHICONE CROSSPOLYMER, PHENOXYETHANOL, PEG-150 DISTEARATE, CETEARYL GLUCOSIDE, DIMETHICONOL, SILICA, POLYSORBATE 60, PARFUM/FRAGRANCE, DISODIUM EDTA, SODIUM POLYACRYLATE, PANTHENOL, CAMELLIA SINENSIS LEAF EXTRACT.

  • QUESTIONS

    Questions? Call 1-800-FOR-AVON or 1-800-265-AVON in Canada.

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of DFBimage of DFBimage of DFB

  • INGREDIENTS AND APPEARANCE
    CLEARSKIN BLEMISH CLEARING  OVERNIGHT TREATMENT
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0327
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0327-21 in 1 CARTON04/20/2015
    1NDC:10096-0327-150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/20/2015
    Labeler - New Avon LLC (080143520)
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