50% UREA NAIL STICK
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urea stick
River's Edge Pharmaceuticals, LLC
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50% Urea Nail StickDESCRIPTION:
River’s Edge 50% Urea Nail Stick is a keratolytic solution, which is
a gentle, yet potent, tissue softener for nails. Each mL of River’s Edge 50% Urea
Nail Stick contains 50% Urea, Disodium EDTA, Hydroxyethylcellulose, Lactic Acid,
Propylene Glycol, Purified Water, Triethanolamine, Xanthan Gum and Zinc Pyrithione.
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 purulent 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, devitalized, and ingrown nails.
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, River’s Edge 50% Urea Nail Stick
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 River’s Edge 50% Urea Nail Stick 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.
Call your doctor for medical advice about side effects. You may report side
effects to the FDA at 1-800-FDA-1088.
DOSAGE AND ADMINISTRATION:
Apply River’s Edge 50% Urea Nail Stick to
diseased or damaged nail tissue twice per day, or as directed by a physician.
HOW SUPPLIED:
River’s Edge 50% Urea Nail Stick, NDC 68032-131-06, is
supplied in a carton containing 6 NAILSTICKS (2.4 mL each).
Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.
Manufactured for:
River's Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Rev. 09/09
131-12
Principal Display Panel - Carton
50% Urea Nail Stick
Rev. 09/09 131-22
NDC 68032-131-06
Rx Only 2.4 mL
Each gram of River’s Edge 50% Urea Nail Stick contains: 50% Urea, Disodium EDTA,
Hydroxyethylcellulose, Lactic Acid, Propylene Glycol, Purified Water, Triethanolamine,
Xanthan Gum and Zinc Pyrithione.
Directions: Apply River’s Edge 50% Urea Nail Stick to diseased or damaged nail
tissue twice a day or as directed by a physician.
FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES, LIPS OR MUCOUS
MEMBRANES. KEEP OUT OF REACH OF CHILDREN.
Manufactured for: River's Edge Pharmaceuticals, LLC Suwanee, GA 30024
| 50% UREA NAIL STICK
50% urea stick |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved other | 06/25/2006 | ||
| Labeler - River's Edge Pharmaceuticals, LLC (133879135) |