Clenziderm m.d. systemacne therapeutic system kit

Spl unclassified section

Daily Care Foaming Cleanser

DRUG FACTS

Active ingredient

Salicylic Acid 2%

Purpose

Acne treatment gel

Uses

  • For the treatment of acne.
  • Dries up acne pimples.
  • Helps prevent new acne pimples.

Warnings

Otc - do not use section

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.

Stop use and ask a doctor if

  • irritation becomes severe.

Otc - keep out of reach of children section

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.

Other information

  • Store away from heat and direct sunlight.
  • Store at controlled room temperature: 15C25C (59F77F).

Inactive ingredients

butyl avocadate, cetyl hydroxyethylcellulose, cocamidopropyl betaine, disodium EDTA, ethoxydiglycol, ext. D&C Violet 2, fragrance, menthol, menthyl lactate, sodium laureth sulfate, sodium lauryl sulfate, water

Questions or comments?

1.800.636.7546MondayFriday 9a.m.4p.m. Pacific Time

Spl unclassified section

Pore Therapy

DRUG FACTS

Active ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Uses

  • For the treatment of acne.
  • Dries up acne pimples.
  • Helps prevent new acne pimples.

Warnings

Otc - do not use section

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.

Stop use and ask a doctor if

  • irritation becomes severe.

Otc - keep out of reach of children section

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

Directions

  • Cleanse the skin thoroughly before applying this product.
  • Shake product well before use.
  • 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.

Other information

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

Inactive ingredients

benzalkonium chloride, benzyl alcohol, ethoxydiglycol, ext. D&C Violet 2, fragrance, glycerin, menthol, menthoxypropanediol, menthyl lactate, SD alcohol 40-B (alcohol denat.), water

Questions or comments?

1.800.636.7546MondayFriday 9a.m.4p.m. Pacific Time

Spl unclassified section

Therapeutic Lotion

DRUG FACTS

Active ingredient

Benzoyl Peroxide 5%

Purpose

Acne treatment lotion

Uses

  • For the treatment of acne.
  • Dries up acne pimples.
  • Helps prevent new acne pimples.

Warnings

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.
  • 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.

Otc - do not use section

Do not use if you

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

Stop use and ask a doctor if

  • irritation becomes severe.

Otc - keep out of reach of children section

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

Directions

  • 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 sensitivitydevelops, stop use of both products and ask a doctor.

Other information

  • Store away from heat and direct sunlight.
  • Store at controlled room temperature: 15C25C (59F77F).

Inactive ingredients

benzyl benzoate, BHT, dicaprylyl ether, dimethyl isosorbide, disodium EDTA, hydroxyethyl acrylate, sodium acryloyldimethyl taurate copolymer, phenoxyethanol, polysorbate 60, propylene glycol, squalane, water

Questions or comments?

1.800.636.7546MondayFriday 9a.m.4p.m. Pacific Time

Ingredients and appearance - Product information

Clenziderm m.d. systemacne therapeutic system kit- Salicylic acid and benzoyl peroxide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0187-6103
Route of Administration Topical

Product Characteristics

Color WHITE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part333D USA

Labeler - Valeant Pharmaceuticals North America LLC( 042230623)

Establishment

Name ID/FEI Business Operations
Valeant Pharmaceuticals North America LLC 042230623 MANUFACTURE( 0187-6103), LABEL( 0187-6103), PACK( 0187-6103), ANALYSIS( 0187-6103)

Principal display panel - kit carton

OBAGI ®

MEDICAL

A DIVISION OF VALEANT PHARMACEUTICALS

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)