FDA Label for Urea Cream 40%
View Indications, Usage & Precautions
- WARNINGS AND PRECAUTIONS
- DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACOKINETICS
- INDICATIONS & USAGE
- CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- PREGNANCY
- NURSING MOTHERS
- ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- OTC - KEEP OUT OF REACH OF CHILDREN
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Urea Cream 40% Product Label
The following document was submitted to the FDA by the labeler of this product Laser Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Warnings And Precautions
Urea Cream 40%
Rx Only For external use only. Not for ophthalmic use.
Description
Description
Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40% contains 40% urea as an active ingredient, and the following inactive ingredients: Carbomer, Dimethyl Isosorbide, Emulsifying Wax, Glycerin, Isopropyl Myristate, Neopentyl Glycol Dicaprylate/Dicaprate, Purified Water, Sodium Hydroxide, Tridecyl Stearate, Tridecyl Trimellilate, and Xanthan Gum.
Urea is a diamide of carbonic acid with the following chemical structure:
Clinical Pharmacology
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
Pharmacokinetics
The mechanism of action of topically applied urea is not yet known.
Indications & Usage
Indications and Usage
For debridement and promotion of healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. 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
Contraindications
Known hypersensitivity to any of the listed ingredients.
Warnings
Warnings
For topical use only. Avoid contact with eyes, lips or mucous membranes.
Precautions
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 and consult a physician.
Pregnancy
PREGNANACY
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 reproductive studies are not always predictive of human response, Urea 40% should be given to a pregnant woman only if clearly needed.
Nursing Mothers
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 Urea 40% is administered to a nursing woman.
Adverse Reactions
Adverse Reactions
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.
Dosage & Administration
Dosage and Administration
Apply Urea 40% to affected skin twice a day, or as directed by your physician. Rub in until completely absorbed.
Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each person's professional opinion and knowledge, upon evaluation of the active ingredients, excipients, inactive ingredients and chemical information provided herein.
How Supplied
How Supplied
Urea 40% Cream 1 oz.(28.35 g): NDC 16477-340-01; Urea 40% Cream 3 oz.(85 g): NDC 16477-340-03; Urea 40% Cream 7 oz.(198.4 g): NDC 16477-340-07
Storage And Handling
Store at room temperature 15 οC - 30 οC (59 οF - 86 ο F). Protect from freezing. Keep bottle tightly closed.
Otc - Keep Out Of Reach Of Children
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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