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Umecta PD

Generic Name: urea
Dosage Form: topical emulsion

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Umecta PD

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 contains40% 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.

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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:

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






Umecta PD  UREA
urea emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:68712-017-01 3 g in 1 PACKET
2 NDC:68712-017-02 198.5 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2007
Labeler - Innocutis Holdings LLC (071501252)
Establishment
Name Address ID/FEI Operations
Sonar Products 104283945 manufacture
Revised: 12/2011
 
Innocutis Holdings LLC
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