Label: CLENZIDERM PORE THERAPY ACNE TREATMENT- salicylic acid liquid

  • 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 December 15, 2011

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Acne treatment

  • Uses

    • for the treatment of acne
    • dries up acne pimples
    • helps prevent new acne pimples
  • Warnings

    For external use only

    When using this product

    • 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

    Stop use and ask a doctor if

    • irritation becomes severe.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • cleanse the skin thoroughly before applying 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.
  • Other Information

    • store away from heat and direct sunlight.
    • store at controlled room temperature: 15°-25°C (59°-77°F).
  • Inactive Ingredients

    Benzalkonium Chloride, Benzyl Alcohol, Ethoxydiglycol, Fragrance, Glycerin, Menthol, Menthoxypropanediol, Menthyl Lactate, SD Alcohol 40-B (Alcohol Denat.), Ext. Violet 2 (CI 60730), Water.

  • Questions?

    (800) 636-7546 Mon-Fri 9:00 am – 4:00 p.m. Pacific Time

  • SPL UNCLASSIFIED SECTION

    Dist. by OMP, Inc., Long Beach, CA 90806

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    OBAGI®

    CLENZIderm M.D.™

    Pore Therapy

    SALICYLIC ACID 2%
    ACNE TREATMENT

    2
    Unclogs pores
    and helps
    clear skin of
    acne-causing
    bacteria.

    4 FL. OZ. (118 mL)

    Principal Display Panel - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CLENZIDERM PORE THERAPY   ACNE TREATMENT
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-110
    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
    ALCOHOL (UNII: 3K9958V90M)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    MENTHYL LACTATE (UNII: 2BF9E65L7I)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-110-60118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D02/01/2007
    Labeler - OMP, INC. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURETEK CORPORATION785961046MANUFACTURE(62032-110) , LABEL(62032-110) , PACK(62032-110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei INC.105803274MANUFACTURE(62032-110) , LABEL(62032-110) , PACK(62032-110) , ANALYSIS(62032-110)
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