TINACTIN® JOCK ITCH, TINACTIN® PLUS
Indications And Clinical Uses:
Topical treatment for tinea pedis, tinea cruris, tinea corporis, and tinea manuum due to infection with T. rubrum, T. mentagrophytes, T. tonsurans, M. audouini, E. floccosum, and for tinea versicolor due to M. furfur. Good results can be anticipated in patients with recent, mild fungus infection of the scalp (tinea capitis) treated with Tinactin solution. An oral antifungal agent such as griseofulvin is required in (1) onychomycosis; and (2) chronic infections of the scalp in which fungi are numerous and widely distributed in the skin and hair follicles, and where kerion formation has occurred. Similarly, an oral antifungal agent may be required in chronic refractory fungus infections of the palms and soles which have not responded to Tinactin. Powder or Solution may be used concurrently for adjunctive local benefit in the treatment of these lesions. Tolnaftate is ineffective in vitro against C. albicans and against gram-negative and gram-positive bacteria.
Known hypersensitivity to any of the components of this preparation.
If no improvement in 4 weeks, diagnosis should be reviewed. In mixed infections where bacteria or nonsusceptible fungi are present, supplementary topical or systemic anti-infective therapy is indicated. In mixed infections of yeasts and susceptible fungi, the yeasts frequently do not survive when the fungus infection is cured. Treatment should be discontinued if patient’s skin disease becomes worse. If sensitization or irritation due to tolnaftate occurs, treatment with the drug should be discontinued.
Keep away from eyes and mucous membranes. Do not inhale powder preparations.
Aerosols: Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperature above 50°C. Do not use in the presence of open flame or spark. For external use only. Avoid inhalation. Keep out of eyes and reach of children.
Tolnaftate preparations are essentially nonsensitizing and do not ordinarily sting or irritate intact or broken skin in either exposed or intertriginous areas. A few cases of mild irritation possibly due to the drug have been reported but not confirmed. One case of sensitization to butylated hydroxytoluene has been confirmed.
Dosage & Administration:
Tinactin: Aerosol Liquid: Apply liberally to the infected area.
Aerosol Powder: Spray liberally from a distance of 15 to 25 cm between toes and on feet, in shoes, socks or on affected area.
Cream: Apply a small amount on the affected area and massage gently until it disappears.
Powder: Apply a small amount to the affected area, rubbing it gently into the lesions.
Solution: 1 or 2 drops are sufficient for an area as large as the hand; 2 or 3 drops cover the toes and interdigital webs of 1 foot. Apply to each lesion and massage gently, then allow to dry.
Treatment twice a day for 2 or 3 weeks is usually adequate, although treatment for 4 to 6 weeks might be required, particularly if some thickening of the skin has occurred. As the primary lesions regress, dermatophytid reactions disappear. In patients with lesions in intertriginous areas or on the pressure points of the feet, a keratolytic agent and longer treatment with tolnaftate might be required. Surgical debridement of dead skin and treatment of callosities on the feet may also be advisable in some cases. Moist compresses promote healing of exudative lesions and do not interfere with the fungicidal action of Tinactin Solution. Any two forms may be used in conjunction, especially in cases of tinea pedis. The aerosol spray or powder dusted periodically into socks and shoes may assist in preventing recurrence of infection.
Tinactin Plus: Aerosol Powder/Powder: These products contain a light fresh fragrance to control odor and starch to absorb moisture.
Availability And Storage:
Tinactin: Aerosol Liquid: Aerosol container contains: tolnaftate USP 0.72 mg/g. Nonmedicinal ingredients: alcohol, butylated hydroxytoluene, polyethylene-polypropylene monobutyl ether and propellant-isobutane. Aerosol containers of 70 g.
Aerosol Powder: Aerosol container contains: tolnaftate USP 10 mg (1%)/g. Nonmedicinal ingredients: alcohol, butylated hydroxytoluene, polyethylene-polypropylene glycol monobutyl ether, propellant-isobutane and talc. Aerosol containers of 120 g.
Cream: Each g contains: tolnaftate USP 10 mg (1%). Nonmedicinal ingredients: butylated hydroxytoluene, carbomer 934P, monoamylamine, polyethylene glycol, propylene glycol and titanium dioxide. Tubes of 15 and 30 g.
Powder: Each g contains: tolnaftate USP 10 mg (1%). Nonmedicinal ingredients: cornstarch and talc. Shaker bottles of 30 g.
Solution: Each mL contains: tolnaftate USP 10 mg. Nonmedicinal ingredients: butylated hydroxytoluene and propylene glycol 400. Plastic dropper bottle of 15 mL.
Tinactin Jock Itch: Aerosol Powder: Aerosol container contains: tolnaftate USP 10 mg (1%)/g. Nonmedicinal ingredients: alcohol, butylated hydroxytoluene, polyethylene-polypropylene glycol monobutyl ether, propellant-isobutane and talc. Aerosol containers of 120 g.
Cream: Each g contains: tolnaftate USP 10 mg (1%) in a bland cream base. Nonmedicinal ingredients: cetostearyl alcohol, chlorocresol, mineral oil, phosphoric acid, polyethylene glycol 1000 monocetyl ether, propylene glycol, sodium hydroxide, sodium phosphate monobasic, water and white petrolatum. Tubes of 15 g.
Tinactin Plus: Aerosol Powder: Aerosol container contains: tolnaftate USP 10 mg (1% w/w)/g. Nonmedicinal ingredients: alcohol, butylated hydroxytoluene, fragrance, PE-PPG monobutyl ether, propellant-isobutane, silica and talc. Aerosol containers of 120 g.
Powder: Each g contains: tolnaftate USP 10 mg (1% w/w). Nonmedicinal ingredients: cellulose, fragrance, starch/acrylates/acylamide copolymer and talc. Shaker bottles of 30 g.
Aerosol preparations do not contain CFCs.
TINACTIN® JOCK ITCH, TINACTIN® PLUS Schering Tolnaftate Topical Antifungal