Prescribing information (package insert) - Uracin
DESCRIPTION
Uracin 20% Cream is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 200 mg of urea in a vehicle consisting of the following inactive ingredients : Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Butyrospermum Parkii (Shea) Butter, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isohexadecane, PEG-100 Stearate, Phenoxyethanol, Polysorbate 80, Purified Water, Sorbitan Oleate, Xanthan Gum.
Urea is a diamide of carbonic acid with the following chemical structure:
CLINICAL PHARMACOLOGY
Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of 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 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. Soothes rough and dry skin.
CONTRAINDICATIONS
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
WARNINGS
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center right away.
Avoid contact with eyes, lips and mucous membranes.
Precautions
General
This product is to be used as directed by a licensed healthcare practitioner 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 licensed healthcare practitioner.
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. (See Warnings) for additional precautions.
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:
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.
To report SUSPECTED ADVERSE REACTIONS, contact PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DOSAGE AND ADMINISTRATION
Apply Uracin 20% Cream to affected area(s) twice daily, or as directed by a licensed healthcare practitioner.
Rub in until completely absorbed.
Apply to diseased or damaged nail(s) twice daily, or as directed by a licensed healthcare practitioner.
HOW SUPPLIED
Uracin™ 20% Cream is supplied in white plastic jars containing 8 oz. (227 g) of cream, NDC 59088-257-16, and 4 oz. (113 g) of cream, NDC 59088-257-08.
STORAGE
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from freezing and excessive heat. Keep container tightly closed.