CLENZIDERM PORE THERAPY ACNE TREATMENT- salicylic acid solution

CLENZIDERM PORE THERAPY by

Drug Labeling and Warnings

CLENZIDERM PORE THERAPY 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]

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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

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Distributed by Obagi Medical Products, a division of
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
®/TM are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates.
© OMP, Inc. www.obagi.com 9426302

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

OBAGI®

MEDICAL

CLENZIderm M.D.™

Pore Therapy

Salicylic Acid 2%
Acne Treatment

5 fl. oz. (148 mL)

INGREDIENTS AND APPEARANCE

CLENZIDERM PORE THERAPY  ACNE TREATMENT
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	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, UNSPECIFIED FORM (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	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(0187-6102) , LABEL(0187-6102) , PACK(0187-6102) , ANALYSIS(0187-6102)