FDA Label for Clenziderm Pore Therapy Acne Treatment

View Indications, Usage & Precautions

Clenziderm Pore Therapy Acne Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Obagi Cosmeceuticals Llc. 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.

Other



Drug Facts

Drug Facts

Drug Facts

Distributed by Obagi Cosmeceuticals LLC,
Long Beach, CA 90806


Active Ingredient



Salicylic acid 2%

Salicylic acid 2%

Benzoyl peroxide 5%


Purpose



Acne treatment

Acne treatment

Acne treatment


Uses



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

Warnings



For external use only

For external use only

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.
    • 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.
      • 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.

Stop Use And Ask A Doctor If



  • irritation becomes severe.
    • irritation becomes severe.
      • irritation becomes severe.

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.

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

Inactive Ingredients



butyl avocadate, cetyl hydroxyethylcellulose, chamomilla recutita (matricaria) flower extract, cocamidopropyl betaine, disodium EDTA, ethoxydiglycol, ext. violet 2, fragrance, glycerin, menthol, menthyl lactate, sodium laureth sulfate, sodium lauryl sulfate, water (aqua)

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

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

1.800.636.7546

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

1.800.636.7546

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


Do Not Use If You



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

Principal Display Panel - Kit Carton



OBAGI®
MEDICAL

CLENZIderm M.D.™ SYSTEM

Acne Therapeutic System

This CLENZIderm M.D. SYSTEM includes:

* Please review the disclaimer below.