Pro-39 Urea by Lifsa Drugs Llc PRO-39 UREA- urea cream

Pro-39 Urea by

Drug Labeling and Warnings

Pro-39 Urea by is a Prescription medication manufactured, distributed, or labeled by Lifsa Drugs Llc . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Pro-39 Urea (Urea 39% Cream) Rx only
For Topical Dermatological Use Only
Rx Only - Caution: Federal Law restricts this product to sale by, or on the order of a licensed healthcare practitioner.

Pro-39 Urea Description

Pro-39 Urea Cream is a potent keratolytic emollient which is a gentle, yet potent, tissue softener for skin and/or nails.
Each gram of Pro-39 Urea Cream contains:
ACTIVE: 39% Urea in a cream base of:
INACTIVES: Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Propylene Glycol, Dimethicone, Melaleuca Alternifolia (Tea Tree) Oil, Helianthus Annuus (Sunflower) Oil, Chamomilla Recutita (Chamomile) Extract, Carbomer, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin.

CHEMISTRY
Urea is a diamide of carbonic acid with the following chemical structure:

Pro-39 Urea - 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 prurient 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

Pro-39 Urea Cream is contraindicated in patients with known hypersensitivity to any of the listed ingredients.

Warnings

For external use only. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin.

Precautions

Stop use and ask a doctor if redness or irritation develops. After applying this medication, wash hands and unaffected areas thoroughly. If swallowed, get medical help or contact Poison Control Center right away. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

PREGNANCY

Pregnancy Category B

Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Pro-39 Urea Cream 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 Pro-39 Urea Cream is administered to a nursing woman.

Adverse Reactions

Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

Pro-39 Urea - Dosage and Administration

Apply Pro-39 Urea Cream to affected skin two to three times per day as needed or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue two to three times per day or as directed by a physician. Best applied to affected areas immediately after showering and just before bedtime.

How is Pro-39 Urea Supplied

Pro-39 Urea (39% Urea Cream) is supplied in:

8oz (227gm) Jar NDC: 72678-034-01

Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). Protect from freezing. [See USP Controlled Room Temperature.]

Manufactured for:
Lifsa Drugs LLC, New Brunswick, NJ 08901

Rx only

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 227 gm Jar Label

Rx only

NDC: 72336-034-01

Pro-39 Urea UREA 39% CREAM

Smooth, Spreadable, Moisturizing

Pro-39’s high amount of urea exhibits intensive keratolyic and peeling effects. Thoroughly nourishes, helping to prevent cracks, and drying of your skin.

FOR TOPICAL USE ONLY

Net WT. 8OZ (227 gm)

Packaging

INGREDIENTS AND APPEARANCE

PRO-39 UREA 
urea cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72336-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	390 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE (UNII: 92RU3N3Y1O)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CHAMOMILE (UNII: FGL3685T2X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72336-034-01	227 g in 1 JAR; Type 0: Not a Combination Product	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/01/2019

Labeler - Lifsa Drugs Llc (081205160)