Clenziderm Normal To Oily Skin
FDA Label NDC 62032-511

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Omp, Inc. for the product Clenziderm Normal To Oily Skin (NDC 62032-511). 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, otc - do not use, 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.

Label Section Quick Index

Other

Daily Care Foaming Cleanser

DRUG FACTS

Pore Therapy

DRUG FACTS

Therapeutic Lotion

DRUG FACTS

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

Active Ingredient

Salicylic Acid 2%

Salicylic Acid 2%

Benzoyl Peroxide 5%

Purpose

Acne treatment gel

Acne treatment

Acne treatment lotion

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.

Otc - Do Not Use

For external use only.

For external use only.

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.
    • 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.
      • 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.

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

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

Benzalkonium Chloride, Benzyl Alcohol, Ethoxydiglycol, Ext. Violet 2 (CI 60730), Fragrance, Glycerin, Menthol, Menthoxypropanediol, Menthyl Lactate, SD Alcohol 40-B (Alcohol Denat.), 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?

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

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

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

Do Not Use If You

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

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)

    Principal Display Panel (Kit Carton)

* Please review the disclaimer below.