{"active_ingredient":["Active Ingredient Lidocaine 5% w/w"],"dosage_and_administration":["Directions When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor."],"effective_time":"20251103","id":"42b6b5fb-7eb0-4368-e063-6294a90aab70","inactive_ingredient":["Inactive Ingredients benzyl alcohol,carbomer hompolymer type C, C10-18 triglycerides, cholesterol, lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopherol, trolamine, water"],"indications_and_usage":["Uses Temporarily relieves the pain and itching due to anorectal disorders."],"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":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 g Tube Carton NDC 75834-141-30 Lidocaine 5% Topical Anesthetic Cream-Anorectal NIVAGEN PHARMACEUTICALS net wt. 30 g (1 oz) PRINCIPAL DISPLAY PANEL - 30 g Tube Carton"],"purpose":["Purpose Topical anesthetic"],"questions":["Questions? 1-877-977-0687"],"set_id":"e4565a04-1304-4f87-8d40-8a4ff72125ae","spl_product_data_elements":["Lidocaine Lidocaine BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) MEDIUM-CHAIN TRIGLYCERIDES CHOLESTEROL LECITHIN, SOYBEAN ISOPROPYL MYRISTATE POLYSORBATE 80 PROPYLENE GLYCOL TOCOPHEROL TROLAMINE WATER LIDOCAINE LIDOCAINE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs to ingredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days"],"storage_and_handling":["Other Information Store at 25°C (77°C); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]."],"version":"7","warnings":["Warnings For external use only. When using this product avoid contact with eyes do not use in large quantities, particularly over large surfaces or blistered areas do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs to ingredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days 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 avoid contact with eyes do not use in large quantities, particularly over large surfaces or blistered areas do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator."]}