LOTRISONE® Cream and Lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of LOTRISONE Cream or Lotion for the treatment of infections caused by zoophilic dermatophytes (eg, Microsporum canis) has not been established. Several cases of treatment failure of LOTRISONE Cream in the treatment of infections caused by Microsporum canis have been reported.

Gently massage sufficient LOTRISONE® Cream or Lotion into the affected skin areas twice a day, in the morning and evening.

LOTRISONE Cream or Lotion should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 g per week of LOTRISONE Cream or amounts greater than 45 mL per week of LOTRISONE Lotion should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after 1 week of treatment with LOTRISONE Cream or Lotion, the diagnosis should be reviewed.

LOTRISONE Cream or Lotion should not be used longer than 4 weeks in the treatment of tinea pedis and amounts greater than 45 g per week of LOTRISONE Cream or amounts greater than 45 mL per week of LOTRISONE Lotion should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with LOTRISONE Cream or Lotion, the diagnosis should be reviewed.

LOTRISONE Cream or Lotion should not be used with occlusive dressings.

LOTRISONE® Cream is supplied in 15-g (NDC 0085-0924-01) and 45-g tubes (NDC 0085-0924-02); boxes of one. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

LOTRISONE® Lotion is supplied in 30-mL bottles (NDC 0085-0809-01), box of one. Store at 25°C (77°F) in the upright position only; excursions permitted between 15°C and 30°C (59°F and 86°F).

SHAKE LOTION WELL BEFORE EACH USE.

Schering Corporation, Kenilworth, NJ 07033, USA. Rev. 01/08. FDA Rev date: 1/25/2008

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