CLENZIDERM NORMAL TO OILY SKIN  ACNE THERAPEUTIC SYSTEM- salicylic acid and benzoyl peroxide 
OMP, INC.

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 NORMAL TO OILY SKIN
ACNE THERAPEUTIC SYSTEM

Daily Care Foaming Cleanser

DRUG FACTS

Active Ingredient

Salicylic Acid 2%

Purpose

Acne treatment gel

Uses

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

Other Information

Inactive Ingredients

Butyl Avocadate, Cetyl Hydroxyethylcellulose, Cocamidopropyl Betaine, Disodium EDTA, Ethoxydiglycol, Ext. Violet 2 (CI 60730), Fragrance, Menthol, Menthyl Lactate, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Water (Aqua).

Questions?

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

Pore Therapy

DRUG FACTS

Active Ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Uses

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

Other Information

Inactive Ingredients

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

Questions?

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

Therapeutic Lotion

DRUG FACTS

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne treatment lotion

Uses

Warnings

For external use only.

Stop use and ask a doctor if

  • irritation becomes severe.

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
  • if pregnant or breast-feeding, ask a health care professional before use.

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide.

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?

1-800-636-7546 Mon–Fri 9:00 am–4:00 pm PST

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

PRINCIPAL DISPLAY PANEL - Kit Carton

OBAGI®

CLENZIderm M.D.™

ACNE THERAPEUTIC SYSTEM

Normal to Oily Skin

PRINCIPAL DISPLAY PANEL - Kit Carton
CLENZIDERM NORMAL TO OILY SKIN   ACNE THERAPEUTIC SYSTEM
salicylic acid and benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-511
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-511-021 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 118 mL
Part 21 BOTTLE, PLASTIC 118 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:62032-111
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 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 (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:62032-111-60118 mL in 1 BOTTLE, PLASTIC
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:62032-110
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 (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:62032-110-60118 mL in 1 BOTTLE, PLASTIC
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:62032-113
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)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-113-6547 mL in 1 BOTTLE, PLASTIC
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 - OMP, INC. (790553353)
Establishment
NameAddressID/FEIBusiness Operations
PURETEK CORPORATION785961046MANUFACTURE(62032-511) , LABEL(62032-511) , PACK(62032-511)
Establishment
NameAddressID/FEIBusiness Operations
Ei INC.105803274MANUFACTURE(62032-511) , LABEL(62032-511) , PACK(62032-511) , ANALYSIS(62032-511)

Revised: 5/2012
Document Id: c048c2d1-4ebd-49dd-a8e4-0c374cd20c1e
Set id: 934ec314-1ab7-45ee-a2fe-8bff3ff981b6
Version: 1
Effective Time: 20120510
 
OMP, INC.