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Urealac

Generic Name: urea lotion
Dosage Form: lotion

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 Lotion (35% Urea) In a vehicle containing Vitamin E, Lactic Acid and Zinc

For external use only. Not for ophthalmic use.

Urealac Description

Urealac (35% Urea) LOTION is a keratolytic emollient, which is a gentle, yet potent, tissue softener for skin. Each gram of Urealac lotion contains: 35% Urea, Carbomer, Cetyl Alcohol, Edetate Disodium, Hydroxyethyl Cellulose, Lactic Acid, Mineral Oil, Polysorbate 80, Purified Water, Sorbitan Stearate, Trolamine, Vitamin E, Xanthan Gum, Zinc Pyrion.

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

Urealac - 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

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.

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 reproductive studies are not always predictive of human response, Urealac (35% Urea) LOTION 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 Urealac (35% Urea) LOTION 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.

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010.

Urealac Dosage and Administration

Apply Urealac (35% Urea) LOTION to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.

How is Urealac Supplied

Urealac (35% Urea) LOTION

7 oz. (207 mL) bottle

11 oz. (325 mL) bottle

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

Protect from freezing.

Rx Only

How to properly use Urealac LOTION (35% Urea)

Gentle keratolytic for mild to moderate dry skin and nail conditions.

Easy steps to gently thin and soften thick, rough or dry skin seen, to various degrees, in psoriasis, xerosis, ichthyosis, keratosis, keratoderma, dermatitis, pruritus, eczema and calluses.

Directions:

  1. Apply Urealac (35% Urea) LOTION to affected skin tissue twice per day, or as directed by a physician.
  2. Rub in until completely absorbed.



Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, N.Y. 11701


MG #20551

Rev 699:01 4/09

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 50383-699-07

Urealac Lotion (35% Urea)

In a vehicle containing Vitamin E, Lactic Acid, and Zinc

For Topical Use Only

 

Rx Only

7 oz. (207 mL)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 50383-699-07

Urealac Lotion (35% Urea)

In a vehicle containing Vitamin E, Lactic Acid and Zinc

Gently keratolytic action for mild to moderate dry skin and nail conditions

For Topical Use Only

 

Rx Only

7 oz. (207 mL)

Urealac 
urea lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50383-699
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 349.46 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER 934  
CETYL ALCOHOL  
EDETATE DISODIUM  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)  
LACTIC ACID  
MINERAL OIL  
POLYSORBATE 80  
WATER  
SORBITAN MONOSTEARATE  
TROLAMINE  
ALPHA-TOCOPHEROL SUCCINATE, D-  
XANTHAN GUM  
PYRITHIONE ZINC  
Packaging
# Item Code Package Description
1 NDC:50383-699-07 1 BOTTLE (BOTTLE) in 1 CARTON
1 207 mL in 1 BOTTLE
2 NDC:50383-699-11 1 BOTTLE (BOTTLE) in 1 CARTON
2 325 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2005 11/03/2011
Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
Revised: 11/2009
 
Hi-Tech Pharmacal Co., Inc.
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