{"active_ingredient":["Active Ingredient: Benzocaine 20%"],"dosage_and_administration":["Directions: Apply only amount needed to the oral mucosa to prevent or relieve pain. Children under 2 years of age: do not use."],"effective_time":"20200514","how_supplied":["HOW SUPPLIED Projel-20 ® , Benzocaine 20% is available in in 60 gram jars (NDC 0362-0123-05)."],"id":"7dcbf553-dd7d-409b-8a8e-aa42621b8b21","inactive_ingredient":["Inactive ingredients: Flavor, polyethylene glycol, sodium saccharin"],"indications_and_usage":["Use: Projel-20 ® is a 20% benzocaine topical anesthetic gel packaged in 60 gram jars for use in the operatory. The gel is indicated for temporary relief of pain associated with minor irritation or injury in the mouth and gums or of pain due to canker sores, denture sores or orthodontic appliances. ProJel-20 ® is available in four flavors: Cherry, Pina Colada, Bubblegum and Mint."],"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. If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center immediately."],"openfda":{},"package_label_principal_display_panel":["Mint Projel Label Mint Projel Label"],"purpose":["Purpose: Oral Anesthetic intended for adults and children 2 years of age and older."],"set_id":"da40f80a-c07b-47a3-a483-a90a681454cb","spl_product_data_elements":["Projel-20 Benzocaine BENZOCAINE BENZOCAINE SACCHARIN SODIUM POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 300"],"spl_unclassified_section":["DO NOT USE • For more than 7 days unless directed by a dentist or physician • If you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other ‘caine’ anesthetics • For teething • In children under 2 years of age","STOP USE AND ASK A DOCTOR IF • Sore mouth symptoms do not improve in 7 days • Swelling, rash or fever develops • Irritation, pain, or redness persists or worsens.","OTHER INFORMATION For professional use only in the practice of dentistry. Store at 20°C - 25°C (68°F - 77°F). Do not permit to freeze.","Manufactured by: SEPTODONT, Inc. 416 S. Taylor Ave Louisville, CO 80027 800-872-8305 | www.septodontusa.com Rev. 10/2018"],"version":"4","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 blood. This can occur even if you have used this product before. Stop use and seek immediate 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 on patients with history of allergy due to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics."],"when_using":["WHEN USING THIS PRODUCT • Do not exceed recommended dosage • Patient should not ingest or swallow • Avoid contact with eyes • Localized allergic reactions may occur after prolonged or repeated use • Discontinue use if irritationinflammation or fever and infection develops"]}