Umecta Mousse PI
Description
Clinical Pharmacology
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, keratoderma, corns, and calluses, as well as damaged, ingrown and devitalized nails.
Contraindications
Warnings
For external use only. Avoid contact with eyes, lips or mucous membranes. Umecta Mousse canister - contents under pressure do not puncture or incinerate. Do not store at temperatures above 120º F.
Precautions
Pregnancy
Nursing Monthers
It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Umecta is administered to a nursing woman.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Adverse Reactions
Transient stinging, burning, itching, or irritation may occur and normally disappear on discontinuing the medication.
Dosage and Administration
Apply Umecta PD bioadhesive emulsion/topical suspension or Umecta mousse to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed
How Supplied
Umecta (urea, 40%) mousse is available in a: 4 oz. can NDC 68712-020-01
Store at controlled room temperature 15-30°C (59-86°F).
Protect from freezing.
Manufactured for:
Innocutis Holdings LLCCharleston, SC 29401Toll Free: 1-800-499-4468www.innocutis.comwww.umecta.com