Description

Rx only
For topical use only
Not for ophthalmic use

Umecta is a keratolytic, emollient which is a gentle, yet potent, tissue softener for nails and skin

Each gram of Umecta PD bioadhesive emulsion and topical suspension contains
40% urea, sodium hyaluronate 0.3%, BHT, butyrospermum parkii fruit oil, citric acid,
dimethylacrylamide (and) acrylic acid (and) polystyrene ethyl methacrylate copolymer,
disodium EDTA, glyceryl stearate, glycine soja sterol, helianthus annuus oil,
hydroxypropylmethyl cellulose, purified water, sodium citrate, stearic acid.

Clinical Pharmacology

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of
skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates
and gently dissolves the intercellular matrix of the nail plate which can result in the softening and eventual debridement
of the nail plate.

Pharmacokinetics

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

Indications and Uses

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

Known hypersensitivity to any of the listed ingredients.

Warnings

For external use only. Avoid contact with eyes, lips or mucous membranes.

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.

Pregnancy Category C

Animal reproduction studies have not been conducted with Umecta. It is also not known
whether Umecta can cause fetal harm when administered to a pregnant woman
or can affect reproductive capacity. Umecta should be given to a pregnant
woman only if clearly needed.

Nursing Mothers

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 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 PD™ (urea, 40% - sodium hyaluronate 0.3%) bioadhesive emulsion
is available in a:

7 oz. bottle
NDC 68712-017-02

Store at controlled room temperature 15-30°C (59-86°F).

Manufactured for:

JSJ Pharmaceuticals
Charleston, SC 29401
Toll Free: 1-800-499-4468
www.jsjpharm.com
www.umecta.com

Image of Label

UMECTA PD UREA
urea emulsion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	68712-017
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UREA)	UREA	400 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE
SHEA BUTTER
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
GLYCERYL MONOSTEARATE
SOYBEAN OIL
SUNFLOWER OIL
HYPROMELLOSES
WATER
SODIUM CITRATE
STEARIC ACID
HYALURONATE SODIUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68712-017-01	3 g In 1 PACKET	None
2	68712-017-02	198.5 g In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2007

Labeler - JSJ Pharmaceuticals (615074866)

Establishment
Name	Address	ID/FEI	Operations
Sonar Products		104283945	manufacture

Revised: 01/2011JSJ Pharmaceuticals