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Keralac: Package Insert / Prescribing Info

Package insert / product label
Generic name: urea
Dosage form: cream
Drug class: Topical emollients

Medically reviewed by Drugs.com. Last updated on Jan 18, 2024.

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

Keralac 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:

structure.jpg

Keralac - 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 for Keralac

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/Side Effects

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

Keralac Dosage and Administration

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

Storage and Handling

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 is Keralac 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

KERALAC
urea cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57883-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA470 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
EUCALYPTUS OIL (UNII: 2R04ONI662)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
ColorwhiteScore
ShapeSize
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57883-401-05142 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2011
2NDC:57883-401-109 in 1 CARTON07/01/201108/31/2020
210 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:57883-401-0410 in 1 CARTON09/22/2017
34 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/01/2011
Labeler - Brava Pharmaceuticals, LLC (078786338)