{"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 • use the tip of the cap to break the seal and open the tube • wash the affected skin with soap and water and dry completely before applying • 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. • 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 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":["<table width=\"100%\"><col width=\"75%\"/><col width=\"25%\"/><tbody><tr><td styleCode=\"Botrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>adults and children 12 years and older<list listType=\"unordered\"><item><caption>&#x2022;</caption>use the tip of the cap to break the seal and open the tube</item><item><caption>&#x2022;</caption>wash the affected skin with soap and water and dry completely before applying</item><item><caption>&#x2022;</caption><content styleCode=\"bold\">for athlete&apos;s foot </content>wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.<list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">between the toes only: </content>apply twice a day (morning and night) for<content styleCode=\"bold\"> 1 week </content>or as directed by a doctor.</item><item><caption>&#x2022;</caption><content styleCode=\"bold\">on the bottom or sides of the foot: </content>apply twice a day (morning and night) for<content styleCode=\"bold\"> 2 weeks </content>or as directed by a doctor.</item></list></item><item><caption>&#x2022;</caption><content styleCode=\"bold\">for jock itch and ringworm: </content>apply once a day (morning<content styleCode=\"bold\"> or </content>night) for<content styleCode=\"bold\"> 1 week </content>or as directed by a doctor.</item><item><caption>&#x2022;</caption>wash hands after each use</item></list></item><item><caption>&#x2022;</caption>children under 12 years: ask a doctor</item></list></td><td styleCode=\"Botrule Toprule \" valign=\"top\"><paragraph>1 week between the toes <renderMultiMedia ID=\"id414\" referencedObject=\"ID_17dcc46f-03c2-47fd-b95d-ea0fac4bafd7\"/> 2 weeks on the bottom or sides of the foot <renderMultiMedia ID=\"id417\" referencedObject=\"ID_8d69313b-9cc4-4511-a181-f69479ccf6fe\"/></paragraph></td></tr></tbody></table>"],"effective_time":"20220701","id":"96ea8a54-d84e-4ac6-9ce1-2624f20a4992","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":["Proficient Rx LP"],"original_packager_product_ndc":["51672-2080"],"package_ndc":["63187-111-15","63187-111-30"],"product_ndc":["63187-111"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["992528"],"spl_id":["96ea8a54-d84e-4ac6-9ce1-2624f20a4992"],"spl_set_id":["76f7525d-2005-4da8-a795-50ede6236c68"],"substance_name":["TERBINAFINE HYDROCHLORIDE"],"unii":["012C11ZU6G"],"upc":["0363187111304"]},"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) 63187-111-30"],"purpose":["Purpose Antifungal"],"set_id":"76f7525d-2005-4da8-a795-50ede6236c68","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: Proficient Rx LP Thousand Oaks, CA 91320"],"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":"6","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."]}