CARMOL 40 - urea lotion
CARMOL 40 - urea cream
CARMOL 40 - urea gel
E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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For external use only. Not for ophthalmic use.

DESCRIPTION:

CARMOL®40 is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of CARMOL®40 (40% Urea) Cream and CARMOL®40 (40% Urea) Lotion consists of 40% urea in a vehicle containing carbomer, cetyl alcohol, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, triethanolamine and xanthan gum. Each gram of CARMOL®40 (40% Urea) GEL consists of 40% urea in a vehicle containing disodium EDTA, glycerin, hydroxyethylcellulose, PEG-6 caprylic/capric glycerides, purified water and xanthan gum.

Urea is a diamide of carbonic acid with the following chemical structure:

chemical structure

CLINICAL PHARMACOLOGY:

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

PHARMACOKINETICS:

The mechanism of action of topically applied Urea is not yet known.

INDICATIONS AND USAGE:

For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

CONTRAINDICATIONS:

Known hypersensitivity to any of the listed ingredients.

WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes.

PRECAUTIONS: This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, CARMOL®40 should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CARMOL®40 is administered to a nursing woman.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

ADVERSE REACTIONS:

Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

DOSAGE AND ADMINISTRATION:

Apply CARMOL®40 to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician. Let dry uncovered or apply and cover with adhesive bandage or gauze secured with adhesive tape.

HOW SUPPLIED:

CARMOL®40 (40% Urea) is supplied as:

CARMOL®40 Lotion:
236.6 mL (8 fl oz) bottle, NDC 10337-656-51

CARMOL®40 Cream:
28.35 g (1 oz) tube, NDC 10337-652-52
85 g (3 oz) tube, NDC 10337-652-19
198.6 g (7 oz) tube, NDC 10337-652-49

CARMOL®40 Gel:
15 mL (1/2 oz) bottle, NDC 10337-657-15

Store at Controlled Room Temperature 15°-30°C (59°-86°F).

Protect from freezing.

Manufactured for:
DERM/arts® Division
DOAK DERMATOLOGICS
A Subsidiary of Bradley Pharmaceuticals, Inc.
383 Route 46 West
Fairfield, NJ 07004-2402 USA
1-800-405-DOAK www.doakderm.com

Manufactured by:
Groupe PARIMA, Inc.
Montreal, QC, H4S 1X6 CANADA

Reg. U.S. Patent Nos.
5,919,470
6,380,236
6,281,239

IL181-R4
Rev 09/06

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 236.6 mL CONTAINER

NDC 10337-656-51

Rx Only
CARMOL®40
(40% Urea) Lotion

Gentle, Yet Potent,
Skin Softening Lotion

For Topical Use Only

DIRECTIONS:
Apply CARMOL®40
to affected area(s).
Rub in until lotion is
completely absorbed.

8 fl. oz. (236.6mL)

DOAK DERMATOLOGICS

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 236.6 mL CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 236.6 mL CARTON

NDC 10337-656-51

Rx Only
CARMOL®40
(40% Urea) Lotion

For Topical Use Only

Gentle,
Yet Potent,
Skin
Softening
Lotion

No
AT Rated Bio-
Equivalent

8 fl. oz. (236.6mL)

DOAK DERMATOLOGICS

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 236.6 mL CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 28.35 g CONTAINER

DIRECTIONS: For use on skin and nail. See box or insert for instructions.
Use only as directed by a physician.

NDC 10337-652-52

Rx Only
CARMOL®40
(40% Urea) Cream
Potent, yet gentle, tissue softener
NET WT. 1oz. (28.35g)

Manufactured for: DERM/arts DIVISION
DOAK DERMATOLOGICS

IT023-R5

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 28.35 g CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 28.35 g CARTON

NDC 10337-652-52

Rx Only
CARMOL®40
(40% Urea) Cream
NET WT. 1oz. (28.35 g)

For Topical Use Only

Potent,
yet gentle,
tissue
softener

No
AT Rated
Bio-
Equivalent

DOAK DERMATOLOGICS

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 28.35 g CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 mL CONTAINER

NDC 10337-657-15

Rx Only
CARMOL®40
(40% Urea) GEL

15 mL

Store at controlled room temperature
15°-30°C (59°-85°F).
Protect from freezing.

DOAK DERMATOLOGICS

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 mL CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 mL CARTON

NDC 10337-657-15

Rx Only
CARMOL®40
(40% Urea) GEL

Potent tissue softener for nails and skin

For
Topical Use
Only

15 mL Bottle
plus Applicator Brush

No
AT Rated
Bio-
Equivalent

DOAK DERMATOLOGICS

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 mL CARTON

CARMOL 40
urea lotion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:10337-656
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UREA)	UREA	.4 mL in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
MINERAL OIL
PETROLATUM
PROPYLENE GLYCOL
WATER
TROLAMINE
XANTHAN GUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:10337-656-51	236.6 mL in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2000

CARMOL 40
urea cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:10337-652
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UREA)	UREA	400 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
MINERAL OIL
PETROLATUM
PROPYLENE GLYCOL
WATER
TROLAMINE
XANTHAN GUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:10337-652-52	28.35 g in 1 TUBE	None
2	NDC:10337-652-19	85 g in 1 TUBE	None
3	NDC:10337-652-49	198.6 g in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2000

CARMOL 40
urea gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:10337-657
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UREA)	UREA	.4 mL in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM
GLYCERIN
WATER
XANTHAN GUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:10337-657-15	15 mL in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2000

Labeler - E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. (043838424)

Establishment
Name	Address	ID/FEI	Operations
Fougera Pharmaceuticals Inc.		043838424	ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Groupe PARIMA Inc.		252437850	manufacture

Revised: 04/2012 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.