Urea

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Urea Recall

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Side Effects & Adverse Reactions

For topical use only. Avoid contact with eyes, lips or mucous membranes.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

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.

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History

There is currently no drug history available for this drug.

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Other Information

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:

Sources

Urea Manufacturers

Trinity Pharmaceuticals, Llc

Urea | Trinity Pharmaceuticals, Llc

Apply Urea 40% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.
Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

No Recall
Stratus Pharmaceuticals, Inc

Urea | Stratus Pharmaceuticals, Inc

Apply UREA 10% CREAM to affected skin twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day or as directed by a physician.

No Recall
Perrigo New York Inc

Urea | Perrigo New York Inc

Apply Urea 40% to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day, or as directed by a physician.

No Recall
Exact-rx, Inc.

Urea | Exact-rx, Inc.

DOSAGE AND ADMINSTRATION: Apply Urea Cream 45% to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician.

No Recall
Exact-rx, Inc.

Urea | Exact-rx, Inc.

DOSAGE AND ADMINISTRATION: Use this product as directed, and regularly, to achieve maximum benefit. Follow all directions on the product package and prescription label. If you are uncertain about any of the information, consult your doctor or pharmacist. Apply to the affected areas of the skin/nails, twice a day or as directed by your doctor. Rub in well until absorbed. As the product dries, the level of urea increases as the level of moisture decreases, allowing some of the urea to crystallize (white color). The product will work properly whether or not the urea can be seen on the surface. Wash hands after applying unless you are treating the hands.

No Recall
Exact-rx, Inc.

Urea | Exact-rx, Inc.

DOSAGE AND ADMINISTRATION: Apply Urea Cream 50% to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day or as directed by a physician.

No Recall
Libertas Pharma, Inc.

Urea | Libertas Pharma, Inc.

Apply 45% Urea Lotion to affected area(s). Rub in until lotion is completely absorbed. Use only as directed by a physician.

No Recall
Ascend Laboratories, Llc

Urea | Ascend Laboratories, Llc

DOSAGE AND ADMINISTRATIONS
Apply to affected skin twice per day, or as directeded by your physician. Rub in until completely absorbed.

KEEP THIS AND ALL OTHER MEDICATIONS OUT OF REACH OF CHILDREN

No Recall
Austin Pharmaceuticals, Llc

Urea | Austin Pharmaceuticals, Llc

Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed.

No Recall
Ascend Laboratories, Llc

Urea | Ascend Laboratories, Llc

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

No Recall
Trinity Pharmaceuticals, Llc

Urea | Trinity Pharmaceuticals, Llc

Apply Urea Cream 39% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.
Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

No Recall