{"active_ingredient":["Active Ingredients: Pramoxine hydrochloride 1% Menthol 0.5%"],"dosage_and_administration":["Directions: • adults and children 12 years and over: apply to affected area 3 to 4 times daily • children under 12 years of age: ask a doctor"],"effective_time":"20171207","id":"873a0104-934c-45e8-849b-693d837da853","inactive_ingredient":["Inactive ingredients: benzyl alcohol, carbomer, methyl gluceth-20, purified water, SD alcohol 40, sodium hydroxide"],"indications_and_usage":["Uses: for temporary relief of pain, itching, burning and/or discomfort associated with: • minor skin irritations • itching and discompofort in the perianal area"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – BOTTLE LABEL NDC 10337-808-41 PrameGel ® ANTI-ITCH (pramoxine hydrochloride 1% and menthol 0.5%) gel For temporary relief of itch and pain. 4 fl oz (118 mL) PharmaDerm ® PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON"],"purpose":["Purpose: Anti-itch, Pain relief"],"set_id":"848cfd76-aa0a-427b-959f-66d2cf5f9a34","spl_product_data_elements":["PrameGel pramoxine hydrochloride 1% and menthol 0.5% PRAMOXINE HYDROCHLORIDE PRAMOXINE MENTHOL, UNSPECIFIED FORM MENTHOL BENZYL ALCOHOL METHYL GLUCETH-20 WATER ALCOHOL SODIUM HYDROXIDE CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)"],"spl_unclassified_section":["Other information: store at room temperature 15°-30° C (59°-86° F) • Please see bottom of the bottle for lot number and expiration date","Questions? call 1-800-645-9833, weekdays, 9 AM-5 PM EST Manufactured for: PharmaDerm ® A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 USA www.pharmaderm.com Manufactured by DPT Laboratories, Ltd. San Antonio, Texas 78215 IL235B R11/11"],"version":"2","warnings":["Warning: For external use only When using this product • avoid contact with eyes and nose • do not apply to large areas of the body • do not put into rectum using fingers, mechanical device or applicator Stop use and ask a doctor If: • condition worsens • symptoms persist for more than 7 days or recur again within a few days • you develop allergic reaction, redness, irritation, swelling or pain • rectal bleeding occurs"]}