CLENZIDERM NORMAL TO DRY SKIN ACNE THERAPEUTIC SYSTEM- glycerin 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 DRY SKIN
ACNE THERAPEUTIC SYSTEM

Daily Care Cream Cleanser

Directions

Wet face with warm water.
Dispense a nickel size amount of Daily Care Cream Cleanser into the palm of your hand.
Gently massage Cleanser over entire face.
Rinse skin thoroughly and pat dry.
Wait 10 minutes to allow skin to dry completely before applying Therapeutic Lotion.

Ingredients

Water, Propylene Glycol, Glycerin, Arginine Cocoate, Disodium Cocoyl Glutamate, Cetyl Alcohol, Sodium Cocoyl Glutamate, Glyceryl Stearate, PEG-100 Stearate, Ammonium Cocoyl Isethionate, Salix Alba (Willow) Bark Extract, Mentha Citrata (Bergamot) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Lavandula Angustifolia (Lavender) Extract, Citrus Medica Limonum (Lemon) Peel Extract, Carbomer, Triethanolamine, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben.

Other Information

Store at controlled room temperature: 15°C–24°C (59°F–75°F).

Therapeutic Lotion

DRUG FACTS

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne treatment

Uses

Treats acne.
Dries up acne pimples.
Helps prevent new acne pimples.

Warnings

For external use only. Do not use

If you have very sensitive skin or are sensitive to benzoyl peroxide.

When using this product

Avoid unneccessary sun exposure and use a sunscreen.
Avoid contact with eyes, lips, and mouth.
This product may bleach hair or dyed fabrics.
Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin. Only one drug should be used unless directed by a doctor.
If you are pregnant or breast-feeding, ask a healthcare professional before use.

Stop use and ask a doctor if

too much irritation or sensitivity develops or increases.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Use once a day or as directed by your physician.
Clean the skin thoroughly before applying.
Pump product 1 time onto fingertip and apply evenly to entire face, avoiding the eyes, nose and mouth.
Allow Therapeutic Lotion to absorb completely before applying Therapeutic Moisturizer.
Because excessive drying of the skin may occur, start with 1 application per day.
If bothersome dryness or peeling occurs, reduce application to every other day.
If going outside, use a sunscreen: Allow Obagi CLENZIderm M.D.™ Therapeutic Lotion to dry, then follow directions in the sunscreen labeling.

Inactive Ingredients

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

Other Information

Store away from heat and direct sunlight. Store at controlled room temperature: 15°C–24°C (59°F–75°F).

Therapeutic Moisturizer

DRUG FACTS

Active Ingredients:Purpose:

Dimethicone 1%

Skin protectant

Glycerin 20%

Skin protectant

Uses

Temporarily protects chapped or cracked skin.
Helps protect from the drying effects of wind and cold weather.

Warnings

For external use only.

When using this product

Do not get into eyes.

Stop use and ask a doctor if

condition worsens.
symptoms last for more than 7 days or clear up and occur again within a few days.

Do not use

deep or puncture wounds.
animal bites.
serious burns.

Children under 6 months: ask a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Cross Polymer, Allantoin, Butylparaben, Cetyl Dimethicone, Corn Starch Modified, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Cross Polymer, Ethylparaben, Isobutylparaben, Lauryl PEG/PPG-18/18 Methicone, Metyhlparaben, Phenoxyethanol, Propylparaben, Triethanolamine, Water.

Dist. By OMP Inc., Long Beach, CA 90802

PRINCIPAL DISPLAY PANEL - Kit Carton

OBAGI®

CLENZIderm M.D.

ACNE THERAPEUTIC SYSTEM

Daily Care Cream Cleanser
Therapeutic Lotion
Therapeutic Moisturizer

Normal to Dry Skin

PRINCIPAL DISPLAY PANEL - Kit Carton
CLENZIDERM NORMAL TO DRY SKIN  ACNE THERAPEUTIC SYSTEM
glycerin and benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-512
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-512-031 in 1 CARTON; Type 0: Not a Combination Product07/01/2007
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 50 mL
Part 21 BOTTLE, PLASTIC 47 mL
Part 1 of 2
CLENZIDERM THERAPEUTIC MOISTURIZER 
glycerin cream
Product Information
Item Code (Source)NDC:62032-114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLPARABEN (UNII: 14255EXE39)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-114-7050 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 finalpart34707/01/2007
Part 2 of 2
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; 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 finalpart333D07/01/2007
Labeler - OMP, INC. (790553353)
Establishment
NameAddressID/FEIBusiness Operations
Ei INC.105803274MANUFACTURE(62032-512) , LABEL(62032-512) , PACK(62032-512) , ANALYSIS(62032-512)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933MANUFACTURE(62032-512)

Revised: 12/2017
Document Id: 4914824e-c261-4902-aea4-39536c4ef902
Set id: 95cf7f25-0416-4b77-ad7c-f382ebd470bb
Version: 2
Effective Time: 20171219
 
OMP, INC.