Keralac

KERALAC- urea cream
Brava Pharmaceuticals, LLC

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.

Rx Only
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

DESCRIPTION:

Each gram contains 470 mg of urea in a vehicle consisting of: purified water, SD alcohol 40B 200 proof, hydroxyethyl cellulose, titanium dioxide, disodium EDTA, eucalyptus oil, menthol and camphor.

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

http://medlibrary.org/lib/images-rx/keralac-1/structure.jpgstructure.jpg

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 skin.

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

INDICATIONS AND USAGE:

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

CONTRAINDICATIONS:

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

WARNING: KEEP OUT OF REACH OF CHILDREN.

PRECAUTIONS:

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

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.

ADVERSE REACTIONS:

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

DOSAGE AND ADMINISTRATION:

Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed.

STORAGE:

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.

NOTICE: Protect from freezing and excessive heat. Keep bottle tightly closed.

HOW SUPPLIED:

5 oz. (142 g) bottles, NDC 57883-401-05

To report a serious adverse event or obtain product information, call (800) 298-1087.

Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX 78230 1355

827734

Label
(click image for full-size original)

KERALAC
urea cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57883-401
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 470 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (SYNTHETIC)
EDETATE DISODIUM
ALCOHOL
EUCALYPTUS OIL
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
MENTHOL
WATER
TITANIUM DIOXIDE
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57883-401-05 142 g in 1 BOTTLE, PLASTIC None
2 NDC:57883-401-10 9 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 10 g in 1 BOTTLE, PLASTIC This package is contained within the CARTON (57883-401-10)
3 NDC:57883-401-04 10 TUBE in 1 CARTON contains a TUBE
3 4 g in 1 TUBE This package is contained within the CARTON (57883-401-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/01/2011
Labeler — Brava Pharmaceuticals, LLC (078786338)

Revised: 12/2018 Brava Pharmaceuticals, LLC

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