Ketoconazole Cream, 2%

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-(1 H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl] piperazine and has the following structural formula:

Molecular Formula: C ₂₆H ₂₈Cl ₂N ₄O ₄

Molecular Weight: 531.43

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 15 g (NDC 51672-1298-1).

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

Drug Facts

Miconazole Nitrate 2% USP

Antifungal

Cures most athlete's foot ( tinea pedis) and ringworm (tinea corporis)

for effective relief of itchy,scaly skin between the toes.

For extenal use only

clean the affected area and dry thoroughly
apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
supervise children in the use of this product
for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
for athlete’s foot and ringworm, use daily for 4 weeks
if condition persists longer, consult a doctor
this product is not effective on scalp or nails.

store at controlled room temperature 15 o-30 oC (59 o-86 oF)

acetic acid, benzyl alcohol, isopropyl alcohol (30%), laureth-4, water

1-800-321-4576 or visit www.pedinol.com

Contents:

NDC 0884-0293-01

1- Pedinol Topical Antifungal 1 fl. oz. (29.57 mL)

NDC 51672-1298-1

1- Ketoconazole Cream 2% 15g

1- Foot File (with extra pads)

6- Nail Files

NDC 51672-1298-1

15 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 - 15 g Tube Carton

PDP

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