{"active_ingredient":["Active Ingredient Benzocaine, 20%"],"do_not_use":["Do Not Use Carton - • more than directed • for more than 7 days unless directed by a dentist or doctor. Tube - • Do not use this product for more than 7 days unless directed by a dentist or physician. • If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or physician promptly. • Do not exceed recommended dosage. • Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other caine anethetics. • Avoid contact with eyes. • Keep this and all medications out of the reach of children. • In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. • Store at controlled room temperature 59° - 86°F (15° - 30°C)."],"dosage_and_administration":["Directions Cut open tip of tube. Adults and children 2 years of age and older, apply to affected area up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of the product. Children under 2 years of age, consult a doctor."],"effective_time":"20250424","id":"4f8a32c9-876b-439c-a8a5-936d2112be7e","inactive_ingredient":["Inactive Ingredients Flavors, PEG 4, PEG 540, PEG 75, PEG 8, Sodium Saccharin, Sorbic Acid."],"indications_and_usage":["Allergy Alert : do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics."],"keep_out_of_reach_of_children":["Keep Out of Reach of Children . In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel NDC 37205-607-05 Compare to Orajel® active ingredient* LEADER® Maximum Strength Oral Pain Relief Anesthetic Gel Benzocaine 20% SATISFACTION GUARANTEED Instant relief of toothache pain. 0.5 oz (14.2 g) 20% carton","Principal Display Panel NDC 37205-607-05 LEADER® Compare to Orajel® active ingredient* Maximum Strength Oral Pain Relief Anesthetic Gel Benzocaine 20% SATSIFACTION GUARANTEED 0.5 oz (14.2 g) 20% tube"],"purpose":["Purpose Oral pain reliever"],"set_id":"72274fff-065b-4c87-9207-68ee8a537618","spl_product_data_elements":["Leader Oral Pain Relief Anesthetic Benzocaine 20% BENZOCAINE BENZOCAINE SACCHARIN SODIUM SORBIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED"],"spl_unclassified_section":["Uses Carton - For the temporary relief of minor toothache, pain and sore mouth associated with canker sores, dentures and orthodontic appliances. Tube – For prompt toothache pain relief and for the temporary relief of minor toothache, pain and sore mouth associated with canker sores, dentures and orthodontic appliances.","Other Information • Do not use if tube tip is cut prior to opening. • Store at room temperature.","This product is not manufactured or distributed by Del Pharmaceuticals, Inc., a subsidiary of Del Laboratories, Inc., owners of the registered trademark Orajel®. DISTRIBUTED BY: CARDINAL HEALTH Dublin, Ohio 43017 USA CIN 4208419 1-800-200-6313 www.myleader.com All Leader Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund. Cat. No. 0443-000 Made in USA 1504430 1304430 Rev. 7/09"],"stop_use":["Stop use and ask a Doctor if: • swelling, rash, or fever develops • irritation, pain or redness persists or gets worse"],"version":"12","warnings":["Warnings"]}