Label: CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM- salicylic acid and benzoyl peroxide kit

  • NDC Code(s): 62032-610-11, 62032-611-01, 62032-612-04, 62032-613-01, view more
    62032-613-09, 62032-613-15
  • Packager: Obagi Cosmeceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 19, 2025

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  • Daily Care Foaming Cleanser 4 fl. oz. (118 mL) AM+PM

  • 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

    • 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

    Benzyl Benzoate, BHT, Dicaprylyl Ether, Dimethyl Isosorbide, Disodium EDTA, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Polysorbate 60, Propylene Glycol, Squalane, Water (Aqua)

  • Questions or comments?

    1.800.636.7546

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

  • Pore Therapy 5 fl. oz. (148 mL) AM+PM

  • 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

    • 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 skin thoroughly before applying this product.
    • Shake product well before use.
    • Place a cotton ball or pad over the pump well and pump 2 to 3 times to saturate, then cover the entire affected area with a thin layer one to three times daily.
    • Allow the product to air-dry completely; do not rinse off.
    • 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

    benzyl alcohol, chamomilla recutita (matricaria) flower extract, ethoxydiglycol, ext. violet 2, fragrance, glycerin, menthol, menthoxypropanediol, menthyl lactate, SD alcohol 40-B, water (aqua)

  • Questions or comments?

    1.800.636.7546

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

  • Therapeutic Lotion 1.6 fl. oz. (47 mL) AM+PM

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl peroxide 5%

  • 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

    • 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
    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with the eyes, lips, and mouth
    • avoid contact with hair and dyed fabrics, which may be bleached by this product
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

    Do not use if you

    • have very sensitive skin.
    • are sensitive to benzoyl peroxide.

    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 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 doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Other information

    • Store away from heat and direct sunlight.
    • Store at controlled room temperature: 15°C–25°C (59°F– 77°F).
  • Inactive ingredients

    benzyl benzoate, BHT, dicaprylyl ether, dimethyl isosorbide, disodium EDTA, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, phenoxyethanol, polysorbate 60, propylene glycol, squalane, 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 - Kit Carton

    OBAGI®
    MEDICAL

    CLENZIderm M.D.® SYSTEM

    Acne Therapeutic System

    This CLENZIderm M.D. SYSTEM includes:

    • (1) Daily Care Foaming Cleanser 4 FL. OZ. (118 mL)
    • (1) Pore Therapy 5 FL. OZ. (148 mL)
    • (1) Therapeutic Lotion 1.6 FL. OZ. (47 mL)
    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    CLENZIDERM M.D. SYSTEM  ACNE THERAPEUTIC SYSTEM
    salicylic acid and benzoyl peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-613
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-613-011 in 1 CARTON01/01/201212/31/2021
    2NDC:62032-613-091 in 1 CARTON11/01/2021
    3NDC:62032-613-151 in 1 CARTON11/01/201212/31/2022
    31 in 1 BAG
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 118 mL
    Part 21 BOTTLE, PLASTIC 148 mL
    Part 31 BOTTLE, PLASTIC 47 mL
    Part 1 of 3
    CLENZIDERM DAILY CARE FOAMING CLEANSER  ACNE TREATMENT
    salicylic acid liquid
    Product Information
    Item 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)  
    WATER (UNII: 059QF0KO0R)  
    BUTYL AVOCADATE (UNII: Q86RQ0D402)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-610-11118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00602/01/2007
    Part 2 of 3
    CLENZIDERM PORE THERAPY  ACNE TREATMENT
    salicylic acid liquid
    Product Information
    Item Code (Source)NDC:62032-612
    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)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    WATER (UNII: 059QF0KO0R)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-612-04148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00602/01/2007
    Part 3 of 3
    CLENZIDERM THERAPEUTIC 
    benzoyl peroxide lotion
    Product Information
    Item Code (Source)NDC:62032-611
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL BENZOATE (UNII: N863NB338G)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-611-0147 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00607/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00601/01/2012
    Labeler - Obagi Cosmeceuticals LLC (790553353)
    Registrant - G.S.COSMECEUTICAL USA, INC. (017014734)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S.COSMECEUTICAL USA, INC.017014734MANUFACTURE(62032-613)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208MANUFACTURE(62032-613)
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