CLENZIDERM DAILY CARE FOAMING CLEANSER ACNE TREATMENT- salicylic acid liquid

CLENZIDERM DAILY CARE FOAMING CLEANSER by

Drug Labeling and Warnings

CLENZIDERM DAILY CARE FOAMING CLEANSER by is a Otc medication manufactured, distributed, or labeled by OBAGI COSMECEUTICAL LLC, G.S.COSMECEUTICAL USA, INC., PURETEK CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.
• 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, 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)

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

OBAGI®
MEDICAL

CLENZIderm M.D.™

Daily Care Foaming Cleanser

Salicylic Acid 2%
Acne Treatment

4 fl. oz. (118 mL)

INGREDIENTS AND APPEARANCE

CLENZIDERM DAILY CARE FOAMING CLEANSER   ACNE TREATMENT
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-610
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)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
CHAMOMILE (UNII: FGL3685T2X)
Glycerin (UNII: PDC6A3C0OX)
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: 62032-610-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2007
2	NDC: 62032-610-10	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	02/01/2007

Labeler - OBAGI COSMECEUTICAL LLC (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
G.S.COSMECEUTICAL USA, INC.		017014734	MANUFACTURE(62032-610)

Establishment
Name	Address	ID/FEI	Business Operations
PURETEK CORPORATION		785961046	MANUFACTURE(62032-610) , LABEL(62032-610) , PACK(62032-610)