{"active_ingredient":["Active ingredient Tolnaftate 1%"],"do_not_use":["Do not use on children under 2 years of age unless directed by a doctor."],"dosage_and_administration":["Directions ■ clean the affected area and dry thoroughly ■ apply a thin layer of the product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles, and skin around the nails or as directed by a doctor ■ supervise children in the use of this product ■ for athlete's foot, pay special attention to spaces between the 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. Use under the direction of a medical practitioner"],"effective_time":"20260511","how_supplied":["How Supplied Tolfyra™ Tolnaftate 1% Antifungal Solution is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush (NDC 85477-331-01)"],"id":"9a2daff0-df69-4dd4-9b2b-84d1b74de374","inactive_ingredient":["Inactive ingredients The inactive ingredients in Tolvyra™ (tolnaftate 1% solution) are purified water, PEG-8, cetearyl alcohol, ceteth-20 phosphate, decetyl phosphate, propylene glycol, cocamidopropyl betaine, polysorbate 20, glyceryl stearate, stearyl alcohol, hydroxyethyl cellulose, imidazolidinyl urea, cetyl alcohol, methylparaben, propylparaben, triethanolamine, and citric acid."],"indications_and_usage":["Uses ■ for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). ■ relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions. ■ for the prevention of most Athlete’s foot with daily use. ■ eliminates fungus on fingers, toes, and around the nails. ■ eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush."],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M005"],"brand_name":["Tolfyra"],"generic_name":["TOLNAFTATE"],"is_original_packager":[true],"manufacturer_name":["Oncora Pharma, LLC"],"package_ndc":["85477-331-01"],"product_ndc":["85477-331"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["313423"],"spl_id":["9a2daff0-df69-4dd4-9b2b-84d1b74de374"],"spl_set_id":["b28ee9f2-fc45-4336-b374-be7aa51d44e9"],"substance_name":["TOLNAFTATE"],"unii":["06KB629TKV"]},"package_label_principal_display_panel":["Tolfyra™ Manufactured in the USA by: Oncora Pharma LLC Dallas TX 75228 For questions or information call toll-free: 833-242-4493 pdp pdp"],"purpose":["Purpose Antifungal"],"set_id":"b28ee9f2-fc45-4336-b374-be7aa51d44e9","spl_product_data_elements":["Tolfyra Tolnaftate TOLNAFTATE TOLNAFTATE WATER PEG-8 CETEARYL ALCOHOL CETETH-20 PHOSPHATE DICETYL PHOSPHATE PROPYLENE GLYCOL COCAMIDOPROPYL BETAINE POLYSORBATE 20 GLYCERYL STEARATE STEARYL ALCOHOL HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) IMIDAZOLIDINYL UREA CETYL ALCOHOL METHYLPARABEN PROPYLPARABEN TRIETHANOLAMINE CITRIC ACID ACETATE"],"spl_unclassified_section":["Other information ■ Store at 15 - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. ■ avoid excessive heat ■ do not use if package is damaged"],"stop_use":["Stop use and ask a doctor ■ for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks ■ for prevention of athlete’s foot - if irritation occurs, discontinue use and consult a doctor"],"version":"6","warnings":["Warnings For external use only Do not use on children under 2 years of age unless directed by a doctor. When using this product ■ do not get into eyes Stop use and ask a doctor ■ for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks ■ for prevention of athlete’s foot - if irritation occurs, discontinue use and consult a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product ■ do not get into eyes"]}