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CLENZIDERM THERAPEUTIC by Valeant Pharmaceuticals North America LLC

Medically reviewed on May 18, 2018

Dosage form: lotion
Ingredients: BENZOYL PEROXIDE 50mg in 1mL
Labeler: Valeant Pharmaceuticals North America LLC
NDC Code: 0187-6101

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

OBAGI®
CLENZIderm M.D.™
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 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

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

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)

CLENZIDERM THERAPEUTIC 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-6101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL BENZOATE 
BUTYLATED HYDROXYTOLUENE 
DICAPRYLYL ETHER 
DIMETHYL ISOSORBIDE 
EDETATE DISODIUM 
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) 
PHENOXYETHANOL 
POLYSORBATE 60 
PROPYLENE GLYCOL 
SQUALANE 
WATER 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0187-6101-1647 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/02/2015
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIOperations
Ei INC.105803274MANUFACTURE(0187-6101), LABEL(0187-6101), PACK(0187-6101), ANALYSIS(0187-6101)

 
Valeant Pharmaceuticals North America LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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