CLENZIDERM THERAPEUTIC- benzoyl peroxide lotion

CLENZIDERM THERAPEUTIC by

Drug Labeling and Warnings

CLENZIDERM THERAPEUTIC 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

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 or 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 sensitivity develops, 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

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PRINCIPAL DISPLAY PANEL - 47 mL Bottle Label

OBAGI®

MEDICAL

CLENZIderm M.D.™

Therapeutic Lotion

Benzoyl Peroxide 5%

Acne Treatment

1.6 fl. oz. (47 mL)

INGREDIENTS AND APPEARANCE

CLENZIDERM THERAPEUTIC 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	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)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SQUALANE (UNII: GW89575KF9)
WATER (UNII: 059QF0KO0R)

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

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Ei INC.		105803274	MANUFACTURE(0187-6101) , LABEL(0187-6101) , PACK(0187-6101) , ANALYSIS(0187-6101)