{"description":["CONTAINS Sodium Fluoride in a proprietary neutral flavored foam base. 0.9% Fluoride Ion from 2% Sodium Fluoride at a neutral pH. This product does not contain chlorofluorocarbon propellant. Sweetened with Sucralose. Does not contain Aspartame or Saccharin. Gluten free."],"effective_time":"20211001","id":"79be0b6b-34c3-4e14-9702-54e7d4f1104e","indications_and_usage":["INDICATIONS For the topical application of fluoride in a neutral base to aid in the protection against dental caries. Ideal for patients with extensive esthetic restorations and/or intolerance to acidic fluorides, Kolorz ® Neutral Foam requires a 4-minute application. Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information. Figure"],"instructions_for_use":["kolorz ® By DMG America Instructions For Use Kolorz Sixty Second Fluoride Foam Kolorz Neutral Fluoride Foam The first time you dispense from a new bottle, gently lift upward on the nozzle to break the protective shipping tab (thin plastic tab located adjacent to \"trigger\"). If this tab is not broken, there could be an initial surge of foam from the dispenser. Dosage and Administration: Shake can vigorously before each use. (Fig. 1) Turn can completely upside down to dispense. Point can towards fluoride applicator tray and slowly press the nozzle to fill tray. Use one press per arch, as foam will expand slightly to fill the tray. (Fig. 2) Dry tooth surface and insert tray(s) in mouth. For Kolorz Sixty Second Fluoride Foam: Have patient bite down lightly but firmly for 1 to 4 minutes; For Kolorz Neutral Fluoride Foam: Have patient bite down lightly but firmly for 4 minutes. Remove tray(s) and have patient expectorate excess Instruct patient not to eat, drink, or rinse for at least 30 minutes after application. How Supplied: Both Kolorz Sixty Second Fluoride Foam and Kolorz Neutral Fluoride Foam are available in 4.4oz. (125g) cans and do not contain chlorofluorocarbon propellant. Caution: For professional use only. Federal U.S.A. Law prohibits dispensing without prescription. Warning: Contents under pressure. Do not puncture or incinerate. Store between 55-80° F. Keep from freezing. Distributed by DMG America 242 South Dean Street Englewood, NJ 07631 USA Tel: 201-894-5505 Fax: 201-894-0213 www.dmg-america.com 395490 Rev. 11/13 Figure Fig. 1 Fig. 2"],"openfda":{"brand_name":["KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["DMG AMERICA, LLC"],"package_ndc":["25047-765-44"],"product_ndc":["25047-765"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["DENTAL"],"rxcui":["688393","688397"],"spl_id":["79be0b6b-34c3-4e14-9702-54e7d4f1104e"],"spl_set_id":["b83c62be-8e9d-4fa2-aa10-d34c88bf2387"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 125 g Can Carton Best Taste... Guaranteed! kolorz ® NEUTRAL Fluoride Foam Triple Mint Neutral Sodium Fluoride Contains 2.0% Sodium Fluoride (0.9% Fluoride Ion) GLUTEN FREE! Contains XYLITOL CAUTION: For professional use only. Store at room temperature. Shake well before each use. NET WT. 4.4 OZ (125g) PRINCIPAL DISPLAY PANEL - 125 g Can Carton"],"set_id":"b83c62be-8e9d-4fa2-aa10-d34c88bf2387","spl_product_data_elements":["KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SUCRALOSE XYLITOL TRIPLE MINT"],"spl_unclassified_section":["EMERGENCY RESPONSE Call Infotrac 1-800-535-5053 Made in USA Distributed by: DMG America LLC. 242 South Dean Street Englewood, NJ 07631 800-662-6383 www.dmg-america.com Rev. 4/13 RE-ORDER #766205"],"version":"3","warnings":["WARNING Avoid spraying toward open flame. Contents under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 55-80° F. Keep from freezing."]}