{"active_ingredient":["Active Ingredients: (%) Purpose Benzocaine USP 7.5% w/w................ Analgesic"],"dosage_and_administration":["Directions Wash hands. Cut open tip of tube. Use your fingertips or cotton applicator to apply a small pea size amount of Finafta Baby and spreadover the gums. Apply to affected area up to 4 times daily or as directed by a physician or healthcare provider. 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":"20220908","id":"e82feab0-a484-9844-e053-2a95a90a5d1d","inactive_ingredient":["Inactive ingredients D&C Yellow No. 10, FD&C Red No. 40, Flavor, Glycerin, PEG-6, PEG-75, PEG-32, Sodium Saccharin, Sorbic Acid, Purified Water"],"indications_and_usage":["USES For the temporary relief of sore gums due to teething in children 2 years or older"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose or allergic reaction, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["FinaftaBabyLabel"],"purpose":["Purpose Oral Pain reliever"],"questions":["Questions or Comments? 305-805-3456 Monday-Friday (9 a.m. - 5 p.m. EST) www.efficientlabs.com Distributed by Efficient Laboratories, Inc. Miami Fl 33166 USA"],"set_id":"404d36c3-19a4-4fe9-803d-db9b910c0652","spl_product_data_elements":["Finafta Baby Benzocaine D&C YELLOW NO. 10 FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL 300 POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 1500 SACCHARIN SODIUM SORBIC ACID WATER BENZOCAINE BENZOCAINE"],"version":"6","warnings":["Warnings METHEMOGLOBINEMIA WARNING Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray or blue colored skin (cyanosis) headached 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 procain, butacaine, benzocaine or other \"caine\" anesthetics. Do not exceed recommended dosage Do not use more than directed more than 7 daysunless told to do so by a dentist or doctor When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult a doctor. Stop use of this product and consult your doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness does not go away, swelling, rash or fever develops Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away."]}