{"active_ingredient":["Active ingredient Terbinafine hydrochloride 1%"],"do_not_use":["Do not use on nails or scalp in or near the mouth or eyes for vaginal yeast infections"],"dosage_and_administration":["Directions adults and children 12 years and over: 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 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"],"effective_time":"20250702","id":"38f65202-ed21-e74d-e063-6294a90a2882","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 jock itch (tinea cruris) relieves itching, burning, cracking and scaling which accompany this condition"],"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":["Silka Jock Itch"],"generic_name":["TERBINAFINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Genomma Lab USA, Inc."],"package_ndc":["50066-208-05"],"product_ndc":["50066-208"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["992528","1739221"],"spl_id":["38f65202-ed21-e74d-e063-6294a90a2882"],"spl_set_id":["326d8586-042f-44f8-8530-e46b7b777bc3"],"substance_name":["TERBINAFINE HYDROCHLORIDE"],"unii":["012C11ZU6G"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 15 g Tube Carton SILKA ® Terbinafine Hydrochloride Cream 1% ANTIFUNGAL CREAM FULL PRESCRIPTION STRENGTH JOCK ITCH CURES MOST JOCK ITCH NET WT 0.5 oz (15 g) PRINCIPAL DISPLAY PANEL - 15 g Tube Carton"],"purpose":["Purpose Antifungal"],"questions":["Questions? call 1 877 99 GENOM (43666)"],"set_id":"326d8586-042f-44f8-8530-e46b7b777bc3","spl_product_data_elements":["Silka Jock Itch Terbinafine Hydrochloride BENZYL ALCOHOL CETYL ALCOHOL CETYL PALMITATE ISOPROPYL MYRISTATE POLYSORBATE 60 WATER SODIUM HYDROXIDE SORBITAN MONOSTEARATE STEARYL ALCOHOL TERBINAFINE HYDROCHLORIDE TERBINAFINE"],"spl_unclassified_section":["Drug Facts","Distributed by: Genomma Lab USA Inc., Houston, TX, 77027"],"stop_use":["Stop use and ask a doctor if too much irritation occurs or gets worse"],"storage_and_handling":["Other information do not use if seal on tube is broken or is not visible store at controlled room temperature 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date"],"version":"2","warnings":["Warnings For external use only Do not use on nails or scalp in or near the mouth or eyes for vaginal yeast infections When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or gets worse 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. If eye contact occurs, rinse thoroughly with water."]}