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 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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  • 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 CARTON; Type 0: Not a Combination Product01/01/201212/31/2021
    2NDC:62032-613-091 in 1 CARTON; Type 0: Not a Combination Product11/01/2021
    3NDC:62032-613-151 in 1 CARTON11/01/201212/31/2022
    31 in 1 BAG; Type 0: Not a Combination Product
    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 FINALpart333D02/01/2007
    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 FINALpart333D02/01/2007
    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 FINALpart333D07/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D01/01/2012
    Labeler - OBAGI COSMECEUTICAL LLC (790553353)
    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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