CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM- salicylic acid and benzoyl peroxide 
OBAGI COSMECEUTICAL 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
ACNE THERAPEUTIC SYSTEM

Daily Care Foaming Cleanser
4 fl. oz. (118 mL) AM+PM

Drug Facts

Active ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Uses

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

Other information

Inactive ingredients

Benzyl Benzoate, BHT, Dicaprylyl Ether, Dimethyl Isosorbide, Disodium EDTA, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Polysorbate 60, Propylene Glycol, Squalane, Water (Aqua)

Questions or comments?

1.800.636.7546

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

Pore Therapy
5 fl. oz. (148 mL) AM+PM

Drug Facts

Active ingredient

Salicylic acid 2%

Purpose

Acne treatment

Uses

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

Other information

Inactive ingredients

benzyl alcohol, chamomilla recutita (matricaria) flower extract, ethoxydiglycol, ext. violet 2, fragrance, glycerin, menthol, menthoxypropanediol, menthyl lactate, SD alcohol 40-B, water (aqua)

Questions or comments?

1.800.636.7546

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

Therapeutic Lotion
1.6 fl. oz. (47 mL) AM+PM

Drug Facts

Active ingredient

Benzoyl peroxide 5%

Purpose

Acne treatment

Uses

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

Other information

Inactive ingredients

benzyl benzoate, BHT, dicaprylyl ether, dimethyl isosorbide, disodium EDTA, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, phenoxyethanol, polysorbate 60, propylene glycol, squalane, water (aqua)

Questions or comments?

1.800.636.7546

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

Distributed by Obagi Cosmeceuticals LLC,
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

OBAGI®
MEDICAL

CLENZIderm M.D.® SYSTEM

Acne Therapeutic System

This CLENZIderm M.D. SYSTEM includes:

PRINCIPAL DISPLAY PANEL - Kit Carton
CLENZIDERM M.D. SYSTEM  ACNE THERAPEUTIC SYSTEM
salicylic acid and benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-613
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-613-011 in 1 CARTON; Type 0: Not a Combination Product01/01/201212/31/2021
2NDC:62032-613-091 in 1 CARTON; Type 0: Not a Combination Product11/01/2021
3NDC:62032-613-151 in 1 CARTON11/01/201212/31/2022
31 in 1 BAG; Type 0: Not a Combination Product
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:62032-610
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)  
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)  
BUTYL AVOCADATE (UNII: Q86RQ0D402)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CHAMOMILE (UNII: FGL3685T2X)  
Glycerin (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-610-11118 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 FINALpart333D02/01/2007
Part 2 of 3
CLENZIDERM PORE THERAPY   ACNE TREATMENT
salicylic acid liquid
Product Information
Item Code (Source)NDC:62032-612
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)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
WATER (UNII: 059QF0KO0R)  
CHAMOMILE (UNII: FGL3685T2X)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-612-04148 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 FINALpart333D02/01/2007
Part 3 of 3
CLENZIDERM THERAPEUTIC 
benzoyl peroxide lotion
Product Information
Item Code (Source)NDC:62032-611
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)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
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)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-611-0147 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 FINALpart333D07/01/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/01/2012
Labeler - OBAGI COSMECEUTICAL LLC (790553353)
Establishment
NameAddressID/FEIBusiness Operations
G.S.COSMECEUTICAL USA, INC.017014734MANUFACTURE(62032-613)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208MANUFACTURE(62032-613)

Revised: 3/2022
Document Id: 75a3409c-a851-4330-a9ba-4f270aa11ae7
Set id: 7710e51a-dd3a-4f44-8c97-c089c6817cb0
Version: 2
Effective Time: 20220308
 
OBAGI COSMECEUTICAL LLC