{"active_ingredient":["Active Ingredient Benzocaine 20%"],"do_not_use":["Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor"],"dosage_and_administration":["Directions do not use tube if it is cut prior to opening cut open tip of tube on score mark use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel apply to affected area up to four times daily or as directed by a dentist or physician Adults and children 2 years of age and older: Apply to affected area Children under 12 years of age should be supervised in the use of this product Children under 2 years of age: Consult a doctor"],"effective_time":"20250219","id":"2782a87e-5b11-4ee5-8649-3f31a52d4bda","inactive_ingredient":["Inactive ingredients Flavor, PEG 540, PEG 6, PEG 75, PEG 8, Sodium Saccharin, Sorbic Acid"],"indications_and_usage":["Uses temporary relief of occasional minor irritation, pain and sore mouth"],"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":{"application_number":["M022"],"brand_name":["Sheffield Pain Relief"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Sheffield Pharmaceuticals LLC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["11527-062-47","11527-062-55"],"pharm_class_cs":["Allergens [CS]"],"pharm_class_epc":["Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"product_ndc":["11527-062"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["238910"],"spl_id":["2782a87e-5b11-4ee5-8649-3f31a52d4bda"],"spl_set_id":["e21abfdd-373d-42af-9535-fe1571382a65"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["Principal Display Panel – 0.33oz Carton Label Sheffield Pharmaceuticals NDC 11527-062-47 Oral Pain Relief Maxium Strength GEL Fast Toothache Pain Reliever 20% Benzocaine Topical Gel NET WT. 0.33 OZ (9.35g) Made in the USA Sheffield Pharma Oragel Carton Sheffield Pharma Oragel tube"],"purpose":["Purpose Oral Pain Reliever"],"set_id":"e21abfdd-373d-42af-9535-fe1571382a65","spl_product_data_elements":["Sheffield Pain Relief BENZOCAINE BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 300 POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 1500 POLYETHYLENE GLYCOL 3350 Saccharin Sodium Sorbic Acid SPEARMINT"],"spl_unclassified_section":["Drug Facts","Other information store at a controlled room temperature 59°-86°F (15°-30°C)"],"stop_use":["Stop use and ask a doctor if swelling, rash or fever develops irritation, pain, or redness persists or worsens"],"version":"6","warnings":["Warnings 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. Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor Stop use and ask a doctor if swelling, rash or fever develops irritation, pain, or redness persists or worsens Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."]}