{"adverse_reactions":["ADVERSE REACTIONS Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticarial, gastric distress, headache, and weakness."],"contraindications":["CONTRAINDICATIONS Do not use if patient has a known allergy to fluoride or any of the other ingredients in this product."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Shake can thoroughly for at least 10 seconds before each use. Hold can completely upside down to dispense. Point can toward applicator tray and slowly press nozzle to fill tray. Dry tooth surface and insert tray(s) into mouth. Have patient bite down for 1 minute or up to 4 minutes. Remove tray(s) and have patient expectorate excess. Instruct patient not to eat, drink, or rinse for 30 minutes. DOSAGE FORMS AND STRENGTHS This topical foam contains 1.23% fluoride ion."],"dosage_forms_and_strengths":["DOSAGE FORMS AND STRENGTHS This topical foam contains 1.23% fluoride ion."],"effective_time":"20181220","id":"b8904fb7-2ab1-4fed-9d64-9c0d03f0bfbf","indications_and_usage":["INDICATIONS AND USAGE For topical application to aid in the prevention of dental caries. Treatment frequency should not exceed 4 treatments per year."],"openfda":{},"overdosage":["OVERDOSAGE If treatment dose is swallowed (less than 100 mg F), administer milk, limewater, or calcium-type antacid. In case of larger doses (1 pint contains 4.5 grams F ion, which is a lethal dose), use ipecac syrup emetic and immediately seek medical help. Overdose symptoms include nausea, vomiting, diarrhea, and abdominal pain."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 125 g Canister Label PATTERSON ® DENTAL NDC# 50227-0511-6 Patterson ® 60-Second Foam Fluoride (APF*) Topical Fluoride Solution *Acidulated Phosphate Fluoride 1.23% Fluoride Ion (pH 3.5) Mint NET WT. 4.4 OZ (125 g) Rx Only Reorder Number 088-6127 Manufactured for: Patterson Dental Supply, Inc. 1031 Mendota Heights Road Saint Paul, MN 55120 Danger: Extremely flammable aerosol. Contains gas under pressure; may explode if heated. Causes serious eye damage. PRINCIPAL DISPLAY PANEL - 125 g Canister Label"],"set_id":"3f6c7e3d-2dfd-4869-95db-2bd0640e8c2d","spl_product_data_elements":["Topical 60 Sec Sodium Fluoride Mint Sodium Fluoride Sodium Fluoride Fluoride Ion SACCHARIN SODIUM Sodium Benzoate SODIUM METHYL COCOYL TAURATE Polyethylene Glycol 400 CETYL PHOSPHATE Cetyl Alcohol OLETH-3 PHOSPHATE Sodium Phosphate, Monobasic, Monohydrate APAFLURANE Benzaldehyde"],"spl_unclassified_section":["INGREDIENTS Purified Water, Heptafluoropropane (Propellant), Denatured Ethyl Alcohol (Spearmint), Sodium Fluoride, Crodafos 03A-LQ, Polyethylene Glycol 400, Crodafos MCASA-PA, Cetyl Alcohol, Sodium Methyl Cocoyl Taurate, Sodium Phosphate Monobasic Monohydrate, Artificial Spearmint Flavor, Sodium Saccharin, Sodium Benzoate","Made in U.S.A. 0531151LA, R2-012018"],"storage_and_handling":["STORAGE Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) [See USP Controlled room temperature.]"],"version":"2","warnings":["WARNINGS AND PRECAUTIONS Do not swallow. Harmful if swallowed. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate can. This product is not intended for home or unsupervised consumer use. Safety and effectiveness below age 3 have not been established. There have been no long-term animal studies with this product to evaluate carcinogenic, mutagenic, or impairment of fertility potential. Laboratory studies have indicated that repeated use of APF may dull porcelain, composite restorations and sealants."]}