Label: CLENZIDERM NORMAL TO DRY SKIN ACNE THERAPEUTIC SYSTEM- glycerin 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 December 19, 2017

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  • Daily Care Cream Cleanser

  • Directions

    •
    Wet face with warm water.
    •
    Dispense a nickel size amount of Daily Care Cream Cleanser into the palm of your hand.
    •
    Gently massage Cleanser over entire face.
    •
    Rinse skin thoroughly and pat dry.
    •
    Wait 10 minutes to allow skin to dry completely before applying Therapeutic Lotion.
  • Ingredients

    Water, Propylene Glycol, Glycerin, Arginine Cocoate, Disodium Cocoyl Glutamate, Cetyl Alcohol, Sodium Cocoyl Glutamate, Glyceryl Stearate, PEG-100 Stearate, Ammonium Cocoyl Isethionate, Salix Alba (Willow) Bark Extract, Mentha Citrata (Bergamot) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Lavandula Angustifolia (Lavender) Extract, Citrus Medica Limonum (Lemon) Peel Extract, Carbomer, Triethanolamine, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben.

  • Other Information

    Store at controlled room temperature: 15°C–24°C (59°F–75°F).

  • Therapeutic Lotion

    DRUG FACTS

  • Active Ingredient

    Benzoyl Peroxide 5%

  • Purpose

    Acne treatment

  • Uses

    •
    Treats acne.
    •
    Dries up acne pimples.
    •
    Helps prevent new acne pimples.
  • Warnings

    For external use only. Do not use

    •
    If you have very sensitive skin or are sensitive to benzoyl peroxide.

    When using this product

    •
    Avoid unneccessary sun exposure and use a sunscreen.
    •
    Avoid contact with eyes, lips, and mouth.
    •
    This product may bleach hair or dyed fabrics.
    •
    Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin. Only one drug should be used unless directed by a doctor.
    •
    If you are pregnant or breast-feeding, ask a healthcare professional before use.

    Stop use and ask a doctor if

    •
    too much irritation or sensitivity develops or increases.

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

  • Directions

    •
    Use once a day or as directed by your physician.
    •
    Clean the skin thoroughly before applying.
    •
    Pump product 1 time onto fingertip and apply evenly to entire face, avoiding the eyes, nose and mouth.
    •
    Allow Therapeutic Lotion to absorb completely before applying Therapeutic Moisturizer.
    •
    Because excessive drying of the skin may occur, start with 1 application per day.
    •
    If bothersome dryness or peeling occurs, reduce application to every other day.
    •
    If going outside, use a sunscreen: Allow Obagi CLENZIderm M.D.™ Therapeutic Lotion to dry, then follow directions in the sunscreen labeling.
  • Inactive Ingredients

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

  • Other Information

    Store away from heat and direct sunlight. Store at controlled room temperature: 15°C–24°C (59°F–75°F).

  • Therapeutic Moisturizer

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active Ingredients:Purpose:

    Dimethicone 1%

    Skin protectant

    Glycerin 20%

    Skin protectant
  • Uses

    •
    Temporarily protects chapped or cracked skin.
    •
    Helps protect from the drying effects of wind and cold weather.
  • Warnings

    For external use only.

    When using this product

    •
    Do not get into eyes.

    Stop use and ask a doctor if

    •
    condition worsens.
    •
    symptoms last for more than 7 days or clear up and occur again within a few days.

    Do not use

    •
    deep or puncture wounds.
    •
    animal bites.
    •
    serious burns.

    •
    Children under 6 months: ask a doctor.

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

  • Directions

    •
    Apply as needed.
  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Cross Polymer, Allantoin, Butylparaben, Cetyl Dimethicone, Corn Starch Modified, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Cross Polymer, Ethylparaben, Isobutylparaben, Lauryl PEG/PPG-18/18 Methicone, Metyhlparaben, Phenoxyethanol, Propylparaben, Triethanolamine, Water.

  • SPL UNCLASSIFIED SECTION

    Dist. By OMP Inc., Long Beach, CA 90802

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    OBAGI®

    CLENZIderm M.D.™

    ACNE THERAPEUTIC SYSTEM

    •
    Daily Care Cream Cleanser
    •
    Therapeutic Lotion
    •
    Therapeutic Moisturizer

    Normal to Dry Skin

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    CLENZIDERM NORMAL TO DRY SKIN  ACNE THERAPEUTIC SYSTEM
    glycerin and benzoyl peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-512
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-512-031 in 1 CARTON; Type 0: Not a Combination Product07/01/2007
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 50 mL
    Part 21 BOTTLE, PLASTIC 47 mL
    Part 1 of 2
    CLENZIDERM THERAPEUTIC MOISTURIZER 
    glycerin cream
    Product Information
    Item Code (Source)NDC:62032-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-114-7050 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 finalpart34707/01/2007
    Part 2 of 2
    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; 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 finalpart333D07/01/2007
    Labeler - OMP, INC. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei INC.105803274MANUFACTURE(62032-512) , LABEL(62032-512) , PACK(62032-512) , ANALYSIS(62032-512)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933MANUFACTURE(62032-512)
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