UREA- urea cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)

Available from:

Trinity Pharmaceuticals, LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails. Known hypersensitivity to any of the listed ingredients.

Product summary:

Urea 40% Cream 1 oz. (28.35 g): NDC 54295-308-15 Urea 40% Cream 3 oz. (85 g): NDC 54295-308-24 Urea 40% Cream 7 oz. (198.4 g): NDC 54295-308-25 Store at room temperature 15°C - 30°C (59°F-86°F). Protect from freezing. Keep bottle tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Marketed by: Trinity Pharmaceuticals LLC 2255 Glades Road Suite 324A Boca Raton, FL 33431 TrinityPharmaLLC.com

Authorization status:

unapproved drug other

Summary of Product characteristics

UREA - UREA CREAM
TRINITY PHARMACEUTICALS, LLC
_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._
----------
UREA CREAM 40%
Rx Only
For external use only. Not for ophthalmic use.
DESCRIPTION
Urea 40% is a keratolytic emollient which is a gentle, yet potent,
tissue softener for nails
and/or skin. Each gram of Urea 40% contains 40% urea as an active
ingredient, and the
following inactive ingredients: Water, Propylene Glycol, Glyceryl
Stearate, Mineral Oil,
Cetyl Alcohol, Carbomer, Petrolatum, Xanthan Gum and Sodium Hydroxide.
Urea is a diamide of carbonic acid with the following chemical
structure:
CLINICAL PHARMACOLOGY
Urea gently dissolves the intracellular matrix which results in
loosening of the horny
layer of the skin and shedding of scaly skin at regular intervals,
thereby softening
hyperkeratotic areas of the skin.
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
pilaris, keratosis palmaris, keratoderma, corns and calluses, as well
as damaged,
ingrown and devitalized nails.
CONTRAINDICATIONS
Known hypersensitivity to any of the listed ingredients.
WARNINGS
For topical 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 and consult a physician.
PREGNANCY: Pregnancy Category B. Animal reproduction studies have
revealed no
evidence of harm to the fetus, however, th