{"active_ingredient":["Active Ingredient Benzocaine, 20%"],"dosage_and_administration":["Directions Adults and children 2 years of age and older: Apply to the affected area. Use 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 this product Children under 2 years of age: Consult a dentist or doctor."],"effective_time":"20231010","id":"0685f576-cf74-4d77-8eb7-ff0cecf21576","inactive_ingredient":["Inactive Ingredients FD&C Red #40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol"],"indications_and_usage":["Uses For the temporary relief of pain associated with canker sores and minor dental procedures."],"keep_out_of_reach_of_children":["Keep Out of Reach of Children . If more than used for pain is accidentially swallowed, get medical help or contact a Poison Control center right away."],"openfda":{"application_number":["M022"],"brand_name":["Iolite"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Dharma Research, Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["53045-136-30"],"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":["53045-136"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL","ORAL"],"spl_id":["0685f576-cf74-4d77-8eb7-ff0cecf21576"],"spl_set_id":["2c9519ab-320d-49da-9deb-97a6168fb088"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["Iolite Oral Anesthetic Gel Strawberry Shortcake with Vitamin E and Xylitol Gluten Free 1.12 oz (32 g) Manufactured by Dharma Research, Inc., 5220 NW 72nd Ave, Unit 15, Miami, FL 33166 1-877-833-3725 www.dharmaresearch.com 20201013_136_RevD"],"purpose":["Purpose Oral anesthetic"],"set_id":"2c9519ab-320d-49da-9deb-97a6168fb088","spl_product_data_elements":["Iolite Benzocaine Benzocaine BENZOCAINE FD&C RED NO. 40 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM .ALPHA.-TOCOPHEROL ACETATE XYLITOL"],"spl_unclassified_section":["Other Information Store at room temperature 59-86°F (15-30°C). Protect from freezing and heat."],"version":"3","warnings":["Warnings Methemoglobinemia warning Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek medical attention if you or a child in your care develops: • pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadedness • fatigue or lack of energy 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 this product for more than 7 days unless directed by a dentist or a doctor. 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 doctor promptly. Do not exceed recommended dosage."]}