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Urealac Topical Suspension

Pronunciation

Generic Name: lactic acid and salicylic acid
Dosage Form: topical suspension

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.

Urealac Topical Suspension (50% Urea) in a lactic acid & salicylic acid vehicle

For external use only. Not for ophthalmic use.

Urealac Topical Suspension Description

Each gram of Urealac Topical Suspension contains 50% urea in a formulation consisting of caprylic/capric triglyceride carbomer, cetyl alcohol, edetate disodium, glycerin, hydroxyethylcellulose, lactic acid, PEG- 8, polysorbate 60, propylene glycol, purified water, salicylic acid, sorbitan stearate, titanium dioxide, triethanolamine, vitamin E and xathan gum.

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

Urealac Topical Suspension - 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.

PHARMACOKINETICS

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

Indications and Usage for Urealac Topical Suspension

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.

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

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. Urealac Topical Suspension should be given to a pregnant women only if clearly needed.

NURSING MOTHERS

It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urealac Topical Suspension 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.

Urealac Topical Suspension Dosage and Administration

Apply Urealac Topical Suspension to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.

How is Urealac Topical Suspension Supplied

Urealac Topical Suspension (50% Urea) is supplied as:

284 g (10 oz) tube.

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

Protect from freezing.

Easy steps to treat dry skin conditions including psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris, keratoderma, dermatitis, pruritus, eczema, corns and calluses.

For skin:

1. Apply Urealac Topical Suspension to affected skin twice per day, or as directed by a physician.

2. Rub in until completely absorbed.


Rx Only



Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, N.Y. 11701


MG #25570

Rev 707:00 01/08

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 50383-708-10

Urealac Topical Suspension

(50% Urea) In a lactic acid & salicylic acid vehicle

For Topical Use Only

Rx Only

Net Wt. 10 oz. (284 g)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 50383-707-10

Urealac Topical Suspension

50% Urea

In a lactic acid and salicylic acid vehicle

Rx Only

For Topical Use Only

Net Wt. 10 oz (284 g)

UREALAC 
urea suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50383-707
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 500 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES  
CARBOMER 934  
CETYL ALCOHOL  
EDETATE DISODIUM  
GLYCERIN  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)  
LACTIC ACID  
POLYOXYL 8 STEARATE  
POLYSORBATE 60  
PROPYLENE GLYCOL  
WATER  
SALICYLIC ACID  
SORBITAN MONOSTEARATE  
TITANIUM DIOXIDE  
TROLAMINE  
ALPHA-TOCOPHEROL SUCCINATE, D-  
XANTHAN GUM  
Packaging
# Item Code Package Description
1 NDC:50383-707-10 1 TUBE (TUBE) in 1 CARTON
1 284 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/01/2008 11/03/2011
Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
Revised: 11/2009
 
Hi-Tech Pharmacal Co., Inc.
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