DailyMed - UREA 40 PERCENT- urea cream

NDC Code(s): 72162-1668-2
Packager: Bryant Ranch Prepack
This is a repackaged label.
Source NDC Code(s): 58657-487

Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated December 24, 2024

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DESCRIPTION:
INGREDIENTS: Each gram - of Urea Cream 40% contains Urea 40% and the - following inactive - ingredients: Carbomer, Cetearyl Alcohol, Glycerin, Glyceryl Stearate SE ...

INGREDIENTS: Each gram

of Urea Cream 40%

contains Urea 40% and the

following inactive

ingredients: Carbomer,

Cetearyl Alcohol, Glycerin,

Glyceryl Stearate SE,

Mineral Oil, Purified Water,

White Petrolatum.

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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 of the ...

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 of the skin.

Pharmacokinetics:

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

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INDICATIONS:
This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses ...

This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.
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CONTRAINDICATIONS: (What is this?)
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
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WARNINGS:
FOREXTERNALUSEONLY.NOTFOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes, lips and mucous membranes. General: This product is to be used as directed by a physician ...

FOREXTERNALUSEONLY.NOTFOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN.

Avoid contact with eyes, lips and mucous membranes.

General:

This product 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 and consult a physician.

Information for Patients:

Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.

Carcinogenesis, Mutagenesis and Impairment of Fertility:

Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed.

Pregnancy:

Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

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ADVERSE REACTIONS:
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.

Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
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DOSAGE AND ADMINISTRATION:
Use as - directed by your physician. See label booklet for full - Prescribing Information.

Use as
directed by your physician.
See label booklet for full
Prescribing Information.
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STORAGE:
Store at room - temperature 15°C-30°C - (59°F-86°F). Protect from freezing. Keep bottle tightly closed.

Store at room
temperature 15°C-30°C
(59°F-86°F).
Protect from freezing.
Keep bottle tightly closed.
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HOW SUPPLIED:
This product is supplied in the following size: NDC 72162-1668-2: 7 oz (198.4 g) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
This product is supplied in the following size:
- NDC 72162-1668-2: 7 oz (198.4 g)
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
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PRINCIPAL DISPLAY PANEL (What is this?)
Urea Cream 40%

Urea Cream 40%

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INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(72162-1668) , RELABEL(72162-1668)

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	RxCUI	RxNorm NAME	RxTTY
1	198342	urea 40 % Topical Cream	PSN
2	198342	urea 400 MG/ML Topical Cream	SCD
3	198342	urea 40 % Topical Cream	SY

Label: UREA 40 PERCENT- urea cream

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General:

Information for Patients:

Carcinogenesis, Mutagenesis and Impairment of Fertility:

Pregnancy:

Nursing Mothers:

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Label: UREA 40 PERCENT- urea cream

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Pharmacokinetics:

General:

Information for Patients:

Carcinogenesis, Mutagenesis and Impairment of Fertility:

Pregnancy:

Nursing Mothers:

Find additional resources

Safety

Related Resources

More Info on this Drug

UREA 40 PERCENT- urea cream

Number of versions: 1

UREA 40 PERCENT- urea cream

UREA 40 PERCENT- urea cream

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UREA 40 PERCENT- urea cream

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