CLENZIDERM NORMAL TO DRY SKIN ACNE THERAPEUTIC SYSTEM- glycerin and benzoyl peroxide kit

CLENZIDERM NORMAL TO DRY SKIN by

Drug Labeling and Warnings

CLENZIDERM NORMAL TO DRY SKIN by is a Otc medication manufactured, distributed, or labeled by OMP, INC., Ei INC., Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 INGREDIENT

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

CLENZIDERM NORMAL TO DRY SKIN  ACNE THERAPEUTIC SYSTEM
glycerin and benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-512

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-512-03	1 in 1 CARTON; Type 0: Not a Combination Product	07/01/2007

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	50 mL
Part 2	1 BOTTLE, PLASTIC	47 mL

Part 1 of 2

CLENZIDERM THERAPEUTIC MOISTURIZER 
glycerin cream

Product Information
Item Code (Source)	NDC: 62032-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-114-70	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/01/2007

Part 2 of 2

CLENZIDERM THERAPEUTIC 
benzoyl peroxide lotion

Product Information
Item Code (Source)	NDC: 62032-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-113-65	47 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/01/2007

Labeler - OMP, INC. (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Ei INC.		105803274	MANUFACTURE(62032-512) , LABEL(62032-512) , PACK(62032-512) , ANALYSIS(62032-512)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	MANUFACTURE(62032-512)