CLENZIDERM PORE THERAPY ACNE TREATMENT- salicylic acid liquid

CLENZIDERM PORE THERAPY by

Drug Labeling and Warnings

CLENZIDERM PORE THERAPY by is a Otc medication manufactured, distributed, or labeled by OMP, INC., PURETEK CORPORATION, Ei INC.. 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

• 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

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 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.

Other Information

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

Inactive Ingredients

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

Questions?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

OBAGI®

CLENZIderm M.D.™

Pore Therapy

SALICYLIC ACID 2%
ACNE TREATMENT

2
Unclogs pores
and helps
clear skin of
acne-causing
bacteria.

4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

CLENZIDERM PORE THERAPY   ACNE TREATMENT
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-110
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: 62032-110-60	118 mL in 1 BOTTLE, PLASTIC

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

Labeler - OMP, INC. (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
PURETEK CORPORATION		785961046	MANUFACTURE(62032-110) , LABEL(62032-110) , PACK(62032-110)

Establishment
Name	Address	ID/FEI	Business Operations
Ei INC.		105803274	MANUFACTURE(62032-110) , LABEL(62032-110) , PACK(62032-110) , ANALYSIS(62032-110)