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Rea Lo 39

Generic Name: urea
Dosage Form: cream

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.

Rea Lo 39

Rx Only

DESCRIPTION

Rea Lo 39™ (Urea 39%) Cream is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin. Each gram contains 390 mg Urea as the active ingredient and the following inactive ingredients: purified water, emulsifying wax, glycerin, isopropyl myristate, sorbitol, neopentyl glycol dicaprylate/dicaprate, tridecyl stearate, tridecyl trimellitate and dimethyl isosorbide.

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

Rea Lo 39 - Clinical Pharmacology

Urea cream 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 exact mechanism of action of topically applied urea is not known.

INDICATION AND USAGE

Rea Lo 39™ (Urea 39%) Cream is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses 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

Urea cream should be used as directed by a physician and should not be used to treat conditions other than those for which it was prescribed. If redness or irritation occurs, discontinue use.

Pregnancy: Category C

Animal reproduction studies have not been conducted with urea cream. It is also not known whether urea cream can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Urea cream should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether urea is excreted in human milk, therefore caution should be exercised when administering to a nursing mother.

Adverse Reactions

Transient stinging, burning, itching or irritation is possible and normally resolves upon discontinuing the medication.

Rea Lo 39 Dosage and Administration

Apply to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.

KEEP THIS AND ALL OTHER MEDICATIONS OUT OF REACH OF CHILDREN

How is Rea Lo 39 Supplied

The Rea Lo™ family of products includes various urea cream and lotion formulations.
The 39% urea products are available as:

Rea Lo 39™ (Urea 39%) Cream is supplied in:

8oz (227g) NDC 0316-07405-08

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

Protect from freezing.

Manufactured by: Crown Laboratories, Inc. Johnson City, TN 37604

Rx Only

P19002.00

Rea Lo 39

NDC 0316-7405-08
Rea Lo 39
(Urea 39%) Cream


For Topical Use Only
Rx Only

8 oz (227 g)

P1910.00

Rea Lo 39 
urea cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0316-7405
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 390 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
POLAWAX POLYSORBATE  
GLYCERIN  
ISOPROPYL MYRISTATE  
SORBITOL  
TRIDECYL STEARATE  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE  
TRIDECYL TRIMELLITATE  
Packaging
# Item Code Package Description
1 NDC:0316-7405-08 1 BOTTLE, PLASTIC in 1 CARTON
1 227 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2014
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
Name Address ID/FEI Operations
Crown Laboratories 079035945 manufacture(0316-7405)
Revised: 08/2014
 
Crown Laboratories
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