Label: CLENZIDERM DAILY CARE FOAMING CLEANSER ACNE TREATMENT- salicylic acid liquid

  • NDC Code(s): 62032-610-04, 62032-610-10, 62032-610-11, 62032-610-50
  • Packager: OBAGI COSMECEUTICAL LLC
  • 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 March 8, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 2.0%

  • 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

    • avoid contact with the eyes. If product gets into the 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, only use one topical acne medication at a time.

    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 entire affected area with a thin layer and rinse thoroughly 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°C–25°C (59°F–77°F).
  • Inactive ingredients

    Butyl Avocadate, Cetyl Hydroxyethylcellulose, Chamomilla Recutita (Matricaria) Flower Extract, Cocamidopropyl Betaine, Disodium EDTA, Ethoxydiglycol, Ext. Violet 2, Fragrance (Parfum), Glycerin, Menthol, Menthyl Lactate, Sodium Chloride, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Water (Aqua)

  • Questions or comments?

    1.800.636.7546 Monday–Friday 9a.m.–4p.m. Pacific Time

  • SPL UNCLASSIFIED SECTION

    Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    OBAGI™
    MEDICAL

    CLENZIderm M.D.®

    Daily Care Foaming Cleanser

    Salicylic Acid 2%
    Acne Treatment

    4 FL. OZ. (118 mL)

    Principal Display Panel - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CLENZIDERM DAILY CARE FOAMING CLEANSER   ACNE TREATMENT
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-610
    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
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Glycerin (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    BUTYL AVOCADATE (UNII: Q86RQ0D402)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-610-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/200712/31/2022
    2NDC:62032-610-11118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2021
    3NDC:62032-610-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/200712/31/2022
    4NDC:62032-610-501000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D02/01/2007
    Labeler - OBAGI COSMECEUTICAL LLC (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S.COSMECEUTICAL USA, INC.017014734MANUFACTURE(62032-610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208MANUFACTURE(62032-610)
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