{"active_ingredient":["Active ingredient Terbinafine hydrochloride 1%"],"do_not_use":["Do not use • on nails or scalp • in or near the mouth or the eyes • for vaginal yeast infections"],"dosage_and_administration":["Directions • adults and children 12 years and older o use the tip of the cap to break the seal and open the tube o wash the affected skin with soap and water and dry completely before applying o for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. ▪ between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. ▪ on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. o for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. o wash hands after each use • children under 12 years: ask a doctor 1 week between the toes 2 weeks on the bottom or sides of the foot Figure 1 Figure 2"],"dosage_and_administration_table":["adults and children 12 years and olderuse the tip of the cap to break the seal and open the tubewash the affected skin with soap and water and dry completely before applyingfor athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.wash hands after each usechildren under 12 years: ask a doctor
•ooo▪▪oo•
1 week between the toes 2 weeks on the bottom or sides of the foot
"],"effective_time":"20250930","id":"02fc7642-968f-4ddf-a86a-146ed1a40162","inactive_ingredient":["Inactive ingredients benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol."],"indications_and_usage":["Uses • cures most athlete's foot (tinea pedis) • cures most jock itch (tinea cruris) and ringworm (tinea corporis) • relieves itching, burning, cracking and scaling which accompany these conditions"],"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":["ANDA077511"],"brand_name":["Terbinafine Hydrochloride"],"generic_name":["TERBINAFINE HYDROCHLORIDE"],"manufacturer_name":["Preferred Pharmaceuticals, Inc"],"original_packager_product_ndc":["51672-2080"],"package_ndc":["68788-9814-1"],"product_ndc":["68788-9814"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["992528"],"spl_id":["02fc7642-968f-4ddf-a86a-146ed1a40162"],"spl_set_id":["6016e546-6c02-4af0-888c-c0899865c5f0"],"substance_name":["TERBINAFINE HYDROCHLORIDE"],"unii":["012C11ZU6G"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 g Carton Cures Most Athlete's Foot Terbinafine Hydrochloride Cream 1% Antifungal Cream Full Prescription Strength NET WT 1 oz (30 g) Terbinafine Hydrochloride Cream 1%"],"purpose":["Purpose Antifungal"],"set_id":"6016e546-6c02-4af0-888c-c0899865c5f0","spl_product_data_elements":["Terbinafine Hydrochloride Terbinafine Hydrochloride Terbinafine Hydrochloride Terbinafine benzyl alcohol cetyl alcohol cetyl palmitate isopropyl myristate polysorbate 60 water sodium hydroxide sorbitan monostearate stearyl alcohol"],"spl_unclassified_section":["Drug Facts","Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Relabeled By: Preferred Pharmaceuticals Inc."],"stop_use":["Stop use and ask a doctor if • too much irritation occurs or gets worse. • side effects occur. You may report side effects to FDA at 1-800-FDA-1088."],"storage_and_handling":["Other information • do not use if seal on tube is broken or is not visible • store at controlled room temperature 20°-25°C (68°-77°F) • see carton or tube crimp for lot number and expiration date"],"version":"9","warnings":["Warnings For external use only Do not use • on nails or scalp • in or near the mouth or the eyes • for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if • too much irritation occurs or gets worse. • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. 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 the eyes. If eye contact occurs, rinse thoroughly with water."]}