CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM- salicylic acid and benzoyl peroxide kit

CLENZIDERM M.D. SYSTEM by

Drug Labeling and Warnings

CLENZIDERM M.D. SYSTEM by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Ei INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

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: 15°C–25°C (59°F–77°F).

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?

1.800.636.7546 Monday–Friday 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

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.

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: 15°C –25°C (59°F –77°F).

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?

1.800.636.7546 Monday–Friday 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.

Do not use if you

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

Stop use and ask a doctor if

• irritation becomes severe.

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: 15°C–25°C (59°F–77°F).

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?

1.800.636.7546 Monday–Friday 9a.m.–4p.m. Pacific Time

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)

INGREDIENTS AND APPEARANCE

CLENZIDERM M.D. SYSTEM  ACNE THERAPEUTIC SYSTEM
salicylic acid and benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-6103

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-6103-01	1 in 1 CARTON; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	118 mL
Part 2	1 BOTTLE, PLASTIC	148 mL
Part 3	1 BOTTLE, PLASTIC	47 mL

Part 1 of 3

CLENZIDERM DAILY CARE FOAMING CLEANSER  ACNE TREATMENT
salicylic acid gel

Product Information
Item Code (Source)	NDC: 0187-6100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHOL (UNII: L7T10EIP3A)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-6100-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/02/2015

Part 2 of 3

CLENZIDERM PORE THERAPY  ACNE TREATMENT
salicylic acid solution

Product Information
Item Code (Source)	NDC: 0187-6102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
BENZYL ALCOHOL (UNII: LKG8494WBH)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
GLYCERIN (UNII: PDC6A3C0OX)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
MENTHOL (UNII: L7T10EIP3A)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-6102-04	148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/02/2015

Part 3 of 3

CLENZIDERM THERAPEUTIC 
benzoyl peroxide lotion

Product Information
Item Code (Source)	NDC: 0187-6101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL BENZOATE (UNII: N863NB338G)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-6101-16	47 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/02/2015

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Ei INC.		105803274	MANUFACTURE(0187-6103) , LABEL(0187-6103) , PACK(0187-6103) , ANALYSIS(0187-6103)