{"active_ingredient":["Active Ingredients: (%) Purpose Benzocaine USP 10%..................Oral Anesthetic"],"do_not_use":["Do not use: for more than 7 days unless directed by a dentist or doctor. For teething in children under 2 years of age"],"dosage_and_administration":["Directions •adults and children over 12 years of age apply to the affected area. Gargle, swish around the mouth or allow to remain in place at least 1 minute and then spit out. 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 the product • Children under 2 years of age: Consult a dentist or doctor"],"effective_time":"20250108","id":"2b3875b5-3b67-b786-e063-6394a90ae218","inactive_ingredient":["Inactive Ingredients: polyethylene glycol"],"indications_and_usage":["Uses For temporary relief of pain associated with the following mouth and gum irritations: toothache sore gums cranker sores braces minor dental procedures"],"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 pregnant or breastfeeding, ask a health professional before use."],"openfda":{},"package_label_principal_display_panel":["Prodigium label"],"purpose":["Purpose Oral Anesthetic"],"questions":["Questions or comments? 787-781-3352"],"set_id":"1e8e0653-2f77-b62d-e063-6294a90a6c12","spl_product_data_elements":["Prodigium Benzocaine 10% PROPYLENE GLYCOL BENZOCAINE BENZOCAINE"],"stop_use":["Stop use and consult a doctor promptly if: symptoms do not improve in 7 days swelling, rash, or fever develop irritation, pain, or redness persist or worsen symptoms persist for more than 7 days allergic reaction occurs"],"version":"2","warnings":["Warnings Do not exceed recommended dosage 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 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 this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other \"caine\" anesthetics."]}