Clenziderm M.d. System Kit
FDA Label NDC 62032-613

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Obagi Cosmeceuticals Llc for the product Clenziderm M.d. System (NDC 62032-613). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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:

  • Daily Care Foaming Cleanser 4 fl. oz. (118 mL)
  • Pore Therapy 5 fl. oz. (148 mL)
  • Therapeutic Lotion 1.6 fl. oz. (47 mL)
  • Principal Display Panel (Kit Carton)

    Principal Display Panel (Kit Carton)

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