Umecta Mousse description, usages, side effects, indications, overdosage, supplying and lots more!

Umecta Mousse

Innocutis Holdings LLC

Umecta Mousse PI

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Description

Rx only
For topical use only
Not for ophthalmic use







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.

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





Umecta Mousse

Urea Foam AEROSOL, FOAM

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:68712-020
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
UREA 400 mg

Inactive Ingredients

Ingredient Name Strength
BUTANE
SHEA BUTTER
CARBOMER 934
SOYBEAN OIL
SUNFLOWER OIL
isobutane
laureth-4
POLYSORBATE 20
propane
water
STEARIC ACID
TROLAMINE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68712-020-01 113.4 in 1 CAN

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2007-09-01


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