Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
DMG AMERICA, LLC
DENTAL
PRESCRIPTION DRUG
For the topical application of fluoride to aid in the protection against dental caries. Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information. 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
unapproved drug other
KOLORZ SIXTY SECOND FLUORIDE FOAM BLUE RASPBERRY- SODIUM FLUORIDE AEROSOL, FOAM KOLORZ SIXTY SECOND FLUORIDE FOAM CHERRY CHEESECAKE- SODIUM FLUORIDE AEROSOL, FOAM KOLORZ SIXTY SECOND FLUORIDE FOAM COTTON CANDY- SODIUM FLUORIDE AEROSOL, FOAM KOLORZ SIXTY SECOND FLUORIDE FOAM TRIPLE MINT- SODIUM FLUORIDE AEROSOL, FOAM DMG AMERICA, LLC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this_ _labeling has not been approved by FDA. For further information about unapproved_ _drugs, click here._ ---------- KOLORZ SIXTY SECOND FLUORIDE FOAM INDICATIONS For the topical application of fluoride to aid in the protection against dental caries. Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information. CONTAINS Sodium Fluoride in a proprietary acidulated phosphate flavored foam base. 1.23% Fluoride Ion is available from 2.72% Sodium Fluoride. Does not contain chlorofluorocarbon propellant. Sweetened with Sucralose. Does not contain Aspartame or Saccharin. Gluten free. ® 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. 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 #766202 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: 1. Shake can vigorously before each use. (Fig. 1) ® 2. Turn can completely upside down to dispense. Point can towards fluoride applicator tray and slowly press the nozzle to fill tray. Use one press Izlasiet visu dokumentu