Umecta Mousse

Innocutis Holdings LLC

Umecta Mousse PI

FULL PRESCRIBING INFORMATION: CONTENTS*

• Description
• Clinical Pharmacology
• Pharmacokinetics
• Umecta Mousse Indications and Usage
• Contraindications
• Warnings
• Precautions
• Pregnancy
• Nursing Monthers
• Side Effects
• Dosage and Administration
• How Supplied

FULL PRESCRIBING INFORMATION

Description

Clinical Pharmacology

Pharmacokinetics

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

Umecta Mousse 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.

Side Effects

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 LLC
Charleston, SC 29401
Toll Free: 1-800-499-4468
www.innocutis.com
www.umecta.com