{"active_ingredient":["ACTIVE INGREDIENT LIDOCAINE HCL 5% EPINEPHRINE (SUPPLIED AS EPINEPHRINE HYDROCHLORIDE) 0.01%"],"dosage_and_administration":["DIRECTIONS ADULTS AND CHILDREN 12 YEARS AND OVER CLEANSE THE AFFECTED AREA WITH MILD SOAP AND WARM WATER RINSE WELL OR PAT WITH AN APPROPRIATE CLEANSING PAD GENTLY DRY BY PATTING OR BLOTTING WITH TOILET TISSUE OR A SOFT CLOTH BEFORE APPLYING THIS PRODUCT USE SPRAY PUMP TO APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 4 TIMES DAILY DO NOT USE MORE OFTEN THAN DIRECTED"],"effective_time":"20260109","id":"47f81e54-0ce3-439d-e063-6294a90a2abe","inactive_ingredient":["INACTIVE INGREDIENTS AQUA, ETHOXYDIGLYCOL, PHENOXYETHANOL, ALLANTOIN, ETHYLHEXYLGLYCERIN"],"indications_and_usage":["USES TEMPORARILY RELIEVES SYMPTOMS DUE TO HEMORRHOIDS, HEMORRHOIDAL TISSUES OR PILES: ITCHING PAIN SORENESS BURNING"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, CALL A POISON CONTROL CENTER OR GET MEDICAL HELP RIGHT AWAY."],"openfda":{"application_number":["M015"],"brand_name":["GOLD LABEL B NUMB"],"generic_name":["LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["SCALP TECH INC"],"package_ndc":["82617-104-59"],"product_ndc":["82617-104"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2601579"],"spl_id":["47f81e54-0ce3-439d-e063-6294a90a2abe"],"spl_set_id":["1211590a-13b5-2e75-e063-6394a90a0f86"],"substance_name":["LIDOCAINE HYDROCHLORIDE","EPINEPHRINE HYDROCHLORIDE"],"unii":["V13007Z41A","WBB047OO38"]},"package_label_principal_display_panel":["GOLD"],"purpose":["PURPOSE LOCAL ANESTHETIC"],"questions":["QUESTIONS? 1 (800) 611-7720"],"set_id":"1211590a-13b5-2e75-e063-6394a90a0f86","spl_product_data_elements":["GOLD LABEL B NUMB LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE PHENOXYETHANOL DIETHYLENE GLYCOL MONOETHYL ETHER WATER ALLANTOIN ETHYLHEXYLGLYCERIN LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS EPINEPHRINE HYDROCHLORIDE EPINEPHRINE"],"storage_and_handling":["OTHER INFORMATION STORE AT ROOM TEMPERATURE (15° - 30°C)"],"version":"2","warnings":["WARNINGS FOR EXTERNAL USE ONLY. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU HAVE HEART DISEASE HIGH BLOOD PLESSURE THYROID DISEASE DIABETES DIFFICULTY IN URINATION TAKE MEDICINE FOR HIGH BLOOD PRESSURE DEPRESSION WHEN USING THIS PRODUCT DO NOT PUT INTO THE RECTUM BY USING FINGERS OR ANY MECHANICAL DEVICE OR APPLICATOR. STOP USE AND ASK A DOCTOR IF BLEEDING OCCURS CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS REDNESS, IRRITATION, SWELLING, PAIN OR OTHER SYMPTOMS OCCUR YOU EXPERIENCE WEAKNESS CONFUSION HEADACHE DIFFICULTY BREATHING PALE, GREY OR BLUE COLOURED SKIN. THESE MIGHT BE SIGNS OF METHEMOGLOBINEMIA, A RARE DISORDER, WHICH MAY APPEAR UP TO 2 HOURS AFTER USE."]}