Podiatrole

(NDC 72835-302-03)

For external use only.
Not for ophthalmic use.

Rx Only

PODIATROLE is supplied as 3 components in a kit:

-2 TUBES OF KETOCONAZOLE CREAM 2%, 30g (60g TOTAL IN KIT) (NDC 51672-1298-2), UREA 20% CREAM, 85g

For the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis. Keratolytic.

First apply ketoconazole cream, 2% to cover the affected and immediate surrounding area. Then apply Urea 20% cream and rub into skin until completely absorbed. Apply twice a day or as directed by your physician. 

FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin.

Do not use if known hypersensitivity to any of the listed ingredients of any of the components included on the kit.

Stop use and ask a doctor if redness or irritation develops. Keep this and all other medications out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

MANUFACTURED FOR:
V2 Pharma, LLC

Portland, OR

Rx Only

Rx Only

Ketoconazole cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of butylated hydroxyanisole (BHA), cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.
Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl] piperazine and has the following structural formula:

Molecular Formula: C26H28Cl2N4O4
Molecular Weight: 531.43

Chemical Structure

When ketoconazole cream, 2% was applied dermally to intact or abraded skin of beagle dogs for 28 consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method having a lower detection limit of 2 ng/mL.
After a single topical application to the chest, back and arms of normal volunteers, systemic absorption of ketoconazole was not detected at the 5 ng/mL level in blood over a 72-hour period.
Two dermal irritancy studies, a human sensitization test, a phototoxicity study and a photoallergy study conducted in 38 male and 62 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity and no photoallergenic potential due to ketoconazole cream, 2%.

Ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.

Ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

Ketoconazole cream, 2% is not for ophthalmic use.

During clinical trials 45 (5.0%) of 905 patients treated with ketoconazole cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with ketoconazole cream developed a painful allergic reaction.
In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with ketoconazole cream or one of its excipients, namely propylene glycol.

Ketoconazole cream, 2% is supplied in 30 g (NDC 51672-1298-2) tubes.

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: March, 2014
PK-2925-4
354

NDC 51672-1298-2
30 g
Ketoconazole
Cream 2%
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
Rx only
Keep this and all medications out of the reach of children.
TARO

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Drug Description

Urea 20%

Keratolytic

Carbomer, Fragrance, Isopropyl Myristate, Isopropyl Palmitate, Propylene Glycol, Water, Sodium Laureth Sulfate, Sodium Hydroxide, Phenoxyethanol, Stearic Acid, and Xanthan Gum.

Apply to the affected areas twice a day or as directed by a physician. Rub into the skin until completely absorbed.

Store at controlled room temperature 15° - 30°C (59° - 86°F). Protect from Freezing. See Crimp and end of carton for Lot Number and Expiration Date.

V2 Pharma, LLC

PODIATROLE

NDC 72835-302-03 RX ONLY

PRINCIPAL DISPLAY PANEL - Kit Carton