CLENZIDERM M.D.- salicylic acid and benzoyl peroxide 
Bausch Health US, LLC

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.

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CLENZIDERM M.D. SYSTEM

Daily Care Foaming Cleanser

DRUG FACTS

Active Ingredient

Salicylic Acid 2%

Purpose

Acne treatment gel

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 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, cocamidopropyl betaine, disodium EDTA, ethoxydiglycol, ext. D&C Violet 2, fragrance, menthol, menthyl lactate, sodium laureth sulfate, sodium lauryl sulfate, water

Questions or comments?

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

Pore Therapy

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

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.
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 sensitivitydevelops, 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 - Kit Carton

OBAGI®

MEDICAL

A DIVISION OF VALEANT PHARMACEUTICALS

CLENZIderm M.D.™ SYSTEM

Acne Therapeutic System

This CLENZIderm M.D. SYSTEM includes:

• Daily Care Foaming Cleanser 4 fl. oz. (118 mL)

• Pore Therapy 5 fl. oz. (148 mL)

• Therapeutic Lotion 1.6 fl. oz. (47 mL)

Clenziderm M.D. System Kit Carton
CLENZIDERM M.D. 
salicylic acid and benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-6103
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-6103-011 in 1 CARTON; Type 0: Not a Combination Product03/02/201505/14/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 118 mL
Part 21 BOTTLE, PLASTIC 148 mL
Part 31 BOTTLE, PLASTIC 47 mL
Part 1 of 3
CLENZIDERM DAILY CARE FOAMING CLEANSER  ACNE TREATMENT
salicylic acid liquid
Product Information
Item Code (Source)NDC:0187-6100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
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)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-6100-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/02/201505/14/2021
Part 2 of 3
CLENZIDERM PORE THERAPY  ACNE TREATMENT
salicylic acid solution
Product Information
Item Code (Source)NDC:0187-6102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-6102-04148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/02/201505/14/2021
Part 3 of 3
CLENZIDERM THERAPEUTIC 
benzoyl peroxide lotion
Product Information
Item Code (Source)NDC:0187-6101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL BENZOATE (UNII: N863NB338G)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SQUALANE (UNII: GW89575KF9)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-6101-1647 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/02/201505/14/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/02/201505/14/2021
Labeler - Bausch Health US, LLC (831922468)

Revised: 6/2015
 
Bausch Health US, LLC