Label: CLENZIDERM NORMAL TO OILY SKIN ACNE THERAPEUTIC SYSTEM- salicylic acid and benzoyl peroxide kit

  • 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 May 10, 2012

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  • SPL UNCLASSIFIED SECTION

    Daily Care Foaming Cleanser

    DRUG FACTS

  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Acne treatment gel

  • 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

    • use AM and PM
    • wet face
    • gently massage product all over face for 20–30 seconds avoiding eye area
    • rinse thoroughly and pat dry
    • wait 10–15 minutes to allow skin to dry completely.
  • Other Information

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

    Butyl Avocadate, Cetyl Hydroxyethylcellulose, Cocamidopropyl Betaine, Disodium EDTA, Ethoxydiglycol, Ext. Violet 2 (CI 60730), Fragrance, Menthol, Menthyl Lactate, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Water (Aqua).

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Pore Therapy

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

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Therapeutic Lotion

    DRUG FACTS

  • Active Ingredient

    Benzoyl Peroxide 5%

  • Purpose

    Acne treatment lotion

  • Uses

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

    For external use only.

    Stop use and ask a doctor if

    • irritation becomes severe.

    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
    • if pregnant or breast-feeding, ask a health care professional before use.

    Do not use if you

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

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

  • Directions

    • clean 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°–25°C (59°–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?

    1-800-636-7546 Mon–Fri 9:00 am–4:00 pm PST

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    OBAGI®

    CLENZIderm M.D.™

    ACNE THERAPEUTIC SYSTEM

    • Daily Care Foaming Cleanser
    • Pore Therapy
    • Therapeutic Lotion

    Normal to Oily Skin

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    CLENZIDERM NORMAL TO OILY SKIN   ACNE THERAPEUTIC SYSTEM
    salicylic acid and benzoyl peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-511
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-511-021 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 118 mL
    Part 21 BOTTLE, PLASTIC 118 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:62032-111
    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 SULFATE (UNII: BPV390UAP0)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    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:62032-111-60118 mL in 1 BOTTLE, PLASTIC
    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:62032-110
    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
    Part 3 of 3
    CLENZIDERM THERAPEUTIC 
    benzoyl peroxide lotion
    Product Information
    Item Code (Source)NDC:62032-113
    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)  
    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:62032-113-6547 mL in 1 BOTTLE, PLASTIC
    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 - OMP, INC. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURETEK CORPORATION785961046MANUFACTURE(62032-511) , LABEL(62032-511) , PACK(62032-511)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei INC.105803274MANUFACTURE(62032-511) , LABEL(62032-511) , PACK(62032-511) , ANALYSIS(62032-511)
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