Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ranvet pty. limited - econazole nitrate - unknown - econazole nitrate imidazole active 0.0 - active constituent

Zimbabwe - English - Medicines Control Authority

varichem pharmaceuticals (pvt) ltd - econazole nitrate - powder; oral - 1 % w/w

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sunward pharmaceutical sdn. bhd. - econazole nitrate -

Malta - English - Medicines Authority

janssen-cilag international nv turnhoutsewes 30, b-2340 beerse, belgium - econazole nitrate, triamcinolone acetonide - cream - econazole nitrate 10 mg/g triamcinolone acetonide 1 mg/g - antifungals for dermatological use

United States - English - NLM (National Library of Medicine)

puretek corporation - econazole nitrate (unii: h438wyn10e) (econazole - unii:6z1y2v4a7m) - econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by trichophyton rubrum, trichophyton mentagrophytes, trichophyton tonsurans, microsporum canis, microsporum audouini, microsporum gypseum, and epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor. econazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ranvet pty. limited - econazole nitrate - topical cream, ointment, paste, gel, lotion - econazole nitrate imidazole active 10.0 mg/g - dermatological preps. - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - dermatophyte infection (ringworm) | mycotic dermatitis | pathogenic mould | pathogenic yeast | ringworm | trichophyton mentagrophytes

Australia - English - Department of Health (Therapeutic Goods Administration)

inova pharmaceuticals (australia) pty ltd - econazole nitrate, quantity: 10 mg/g - cream - excipient ingredients: purified water; butylated hydroxyanisole; benzoic acid; liquid paraffin; oleth-5; peg-7 stearate; fragrance (perfume) - pevaryl topical preparations are indicated in the treatment of dermatomycoses caused by dermatophytes (e.g. trichophyton rubrum, t. mentagrophytes, epidermophyton floccosum) and yeasts (e.g. candida albicans, c. guilliermondi, torulopsis spp, malassezia furfur).

Ireland - English - HPRA (Health Products Regulatory Authority)

janssen-cilag ltd - econazole nitrate - pessary - 150 milligram - econazole

United States - English - NLM (National Library of Medicine)

resilia pharmaceuticals, inc. - econazole nitrate (unii: h438wyn10e) (econazole - unii:6z1y2v4a7m) - ecoza (econazole nitrate) topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by trichophyton rubrum, trichophyton mentagrophytes, and epidermophyton floccosum in patients 12 years of age and older. none. pregnancy category c there are no adequate and well-controlled trials with ecoza topical foam in pregnant women. ecoza topical foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. fetotoxic or embryotoxic effects were observed in segment i oral studies with rats receiving 10 to 40 times the human dermal dose. similar effects were observed in segment ii or segment iii studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose. it is not known whether econazole nitrate is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when econazole nitrate is administered to a nursing woman. following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. of the 173 subjects treated with ecoza topical foam, 1% in the clinical trials, 2 subjects were 12 to 17 years old. in a pediatric maximal use trial, ecoza topical foam, 1% was applied once daily to eighteen subjects aged 12 to 17 years with interdigital tinea pedis for 28 days [ see clinical pharmacology (12.3) ]. the safety findings for subjects 12 to 17 years were similar to those in adult population. of the 173 subjects treated with ecoza topical foam, 1% in the adult clinical trials, 6 subjects were 65 years or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. do not use ecoza topical foam in your eyes or vagina. parts of ecoza topical foam canister. (see figure a) how to apply ecoza topical foam: how should i store ecoza topical foam? - store ecoza topical foam at room temperature, between 68°f to 77°f (20°c to 25°c). - do not refrigerate or freeze ecoza topical foam. - do not store ecoza topical foam in direct sunlight. - ecoza topical foam is flammable. keep the ecoza topical foam canister away from heat and temperatures above 120°f (49°c), even if the canister is empty. - do not puncture or burn the ecoza topical foam canister. keep ecoza topical foam and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured for resilia pharmaceuticals, inc., atlanta, ga 30328 issued: 12/2023

Ireland - English - HPRA (Health Products Regulatory Authority)

janssen sciences ireland uc - econazole nitrate - pessary - 150 milligram(s) - imidazole derivatives; econazole