Label: COVER AND CONCEAL BLEMISH CONCEALER- 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 April 15, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient:                          

    Salicylic Acid 1%                         

  • PURPOSE

    Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    Use Helps clear acne

     

  • WARNINGS


    Warnings  For external use only
  • DRUG INTERACTIONS

    Using this product at the same time as other topical acne medications may increase dryness or irritation of the skin.  If this occurs only one medication should be used unless directed by a doctor.
  • WHEN USING

    When using this product avoid contact with eyes
    If contact occurs, flush thoroughly with water
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children

    If swallowed get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • Cleanse skin thoroughly before applying
    • Cover the affected area with a thin layer 1 to 3 times a day
    • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily or as directed by doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients
    Water, Cyclomethicone, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Talc, Dimethicone, Tribehenin, Polyisobutene, Boron Nitride, Methyl Methacrylate Crosspolymer, Nylon-12, Synthetic Wax, Microcrystalline Wax, Disteardimonium Hectorite, PEG/PPG-18/18 Dimethicone, Trimethylsiloxysilicate, Triethoxycaprylylsilane, HDI/Trimethylol Hexyllactone Crosspolymer, Sodium Chloride, Propylene Carbonate, Phenoxyethanol, Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben
    May contain
    Titanium Dioxide, Iron Oxides

  • PRINCIPAL DISPLAY PANEL

    Image for blemishconcealer Enter section text here

  • INGREDIENTS AND APPEARANCE
    COVER AND CONCEAL BLEMISH CONCEALER 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid1 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59735-300-081 in 1 BLISTER PACK
    18 g in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33307/20/2004
    Labeler - Biocosmetics research labs (078870292)
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