{"description":["General Information AMD Medicom Inc. DentiCare Pro-Freeze Topical Anesthetic Gel Cherry 1 oz./ 28.4 g NDC 64778-0394-1 DIN 02318148 Rx Only in US Item code 10039-CH"],"effective_time":"20201209","id":"b60e5b37-e699-d454-e053-2995a90aee59","indications_and_usage":["Indications and Directions Indications: For rapid and long lasting topical anesthesia Directions: Apply 0.2mL of gel to the desired area using a cotton swab Active ingredients: Benzocaine 18.0% w/w, Tetracaine Hydrochloride 2.0% w/w"],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel Panel 1 Panel 2"],"set_id":"324146a5-e473-4a54-8543-38ee567e815e","spl_product_data_elements":["Denti-Care Denti-Freeze Topical Anesthetic Cherry benzocaine, tetracaine hydrochloride BENZOCAINE BENZOCAINE TETRACAINE HYDROCHLORIDE TETRACAINE"],"spl_unclassified_section":["Contact Information Made in USA for AMD Medicom Inc. 2555 Chemin de l’Aviation Pointe-Claire, Montreal, Quebec, Canada H9P 2Z2 Questions: 1-800-361-2862 www.medicom.com"],"storage_and_handling":["Storage Store at a temperature between 15ºC and 25ºC (59ºF - 77ºF)"],"version":"4","warnings":["Warnings Warning: KEEP OUT OF REACH OF CHILDREN Do not use if allergic to benzocaine or any other ingredient in the product. Use with caution in children. Do not use in large quantities or over large areas of the body. Methemoglobinemia Warning: Products containing Benzocaine 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 this product was used before. Stop use and seek immediate attention if you or your child develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or light-headedness and fatigue or lack of energy. Drug Facts Table: https://www.medicom.com/en/products/61/pro-freeze-topical-anesthetic-gel/50/pro-freeze-topical-anesthetic-gel-18-benzocaine-2-tetracaine"],"warnings_and_cautions":["Warnings and Precautions/ Drug Interactions/ Patient Counceling Information Warning 1"]}