FDA Label for Clenziderm Normal To Dry Skin Acne Therapeutic System

View Indications, Usage & Precautions

Clenziderm Normal To Dry Skin Acne Therapeutic System Product Label

The following document was submitted to the FDA by the labeler of this product Omp, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.
    • •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.
      • •Apply as needed.

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).

Store away from heat and direct sunlight. 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.
    • •Temporarily protects chapped or cracked skin.
    • •Helps protect from the drying effects of wind and cold weather.

Otc - Do Not Use



For external use only. Do not use

  • •If you have very sensitive skin or are sensitive to benzoyl peroxide.
  • For external use only.


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.
    • •Do not get into eyes.

Stop Use And Ask A Doctor If



  • •too much irritation or sensitivity develops or increases.
    • •condition worsens.
    • •symptoms last for more than 7 days or clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children



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

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


Inactive Ingredients



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

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.


Therapeutic Moisturizer



DRUG FACTS


Otc - Purpose



Active Ingredients:Purpose:

Dimethicone 1%

Skin protectant

Glycerin 20%

Skin protectant


Do Not Use



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

Otc - Ask Doctor



  • Children under 6 months: ask a doctor.

Other



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


Principal Display Panel - Kit Carton



OBAGI®

CLENZIderm M.D.

ACNE THERAPEUTIC SYSTEM

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