NUPRO 5% Sodium Fluoride White Varnish

Texto original en francés.

Producto de salud natural autorizado en Canadá

Titular

Dentsply Canada Ltd.

NPN o DIN-HM

80046747

Estado

Licencia activa

Fecha de licencia

29 de noviembre de 2013

Fecha de revisión

8 de octubre de 2026

Forma

Vernis

Vía de administración

Dentaire

Tipo de solicitud

TPD Cat IV/LS

Composición

Composición medicinal no indicada.

Ingredientes no medicinales

Hydrogenated rosin, Méthacrylate de bisoxyhydroxypropyl d'isopropylidènediphényle, Saveur de menthe, Dioxyde de titane, Bubblegum flavour, Saveur de raisin, Saveur de caramel, Alcool isopropylique, Saveur de framboise, Sucralose

Dosis recomendadas en Canadá

Usos autorizados en Canadá

NUPRO 5% Sodium Fluoride White Varnish prevents, fights and/or protects against cavities/caries, reduces the incidence of cavities/caries, helps prevent tooth decay, and provides effective fluoride protection.

Texto original en inglés.

Un uso autorizado en Canadá no es una declaración de propiedades saludables autorizada en la Unión Europea. Consulte el registro de declaraciones de propiedades saludables.

Advertencias en Canadá

Cautions and Warnings : Fluoride varnish contains ingredients that may be irritating to the skin and eyes. Avoid con tact with soft oral tissues, eyes and skin. If contact with soft oral tissue occurs, remove by gentle brushing. If accidental contact with eyes occurs, flush affected area with generous amounts of water and seek medical attention. If accidental contact with skin occurs, wash immediately with soap and water. Keep out of reach of children. Caution: Flammable. See MSDS. For dental professional use only. 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. For single use only. This risk of reuse of product for another patient could result in cross-contamination. Remove contact lenses, if present and easy to do and continue rinsing. If skin irritation or rash occurs: Get medical advice/attention. Take off contaminated clothing and wash it before reuse. If swallowed, call a POISON CENTER/doctor/physician/first aider/if you feel unwell. If inhaled, remove person to fresh air and keep comfortable for breathing. Rinse mouth. Keep away from heat, hot surfaces, sparks, open flames and othe ignition sources. No smoking. Use only outdoors or in well-ventilated area. Ground/bond container and receiving equipmwnt. Use explosion-proof electrical/ventilating/lighting/intrinsically safe equipment. Use only non-sparking tools. Take precautionary measures against static discharge. In case of fire: Use alcohol resistant foam or normal protein foam to extonguish. Avoid release to the enviornment. Contaminated work clothing must not be allowed out of the workplace. Wear protective gloves, protective clothing, eye protection and face protection. Wash all exposed external body areas thoroughly after handling. Do not eat, drink or smoke when using this product. Avoid breathing mist/vapours/spray. Store in a well-ventilated place. Keep cool. Store locked up. Keep container tightly closed. Dispose of contents/container to authorized hazardous or special waste collection point in accordance with any local regulation.

Texto original en inglés.

Contra-Indications : Contraindicated for use with patients with: Ulcerative gingivitis or stomatitis; Know sensitivity to colophony (kolophonium, rosin, or resembling agents). Not to be used as a systemic treatment.

Texto original en inglés.

Known Adverse Reactions : Edematous swelling have been reported in rare instances after application to extensive surfaces. Dyspnea (difficulty or laboured breathing) associated with asthmatic children, has been reported in unique situations. Patients having sensitive digestive systems may experience nausea, usually after prolonged treatment. If needed, the varnish can easily be removed by toothbrushing and rinsing. Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. not recommended for children under 6 years of age. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dematitis, urtcaria, gastric distress, headache and weakness.

Texto original en inglés.

Fuente

Ficha oficial de Health Canada, licencia 80046747

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias, consultado el 27 de octubre de 2026.

Contains information licensed under the Open Government Licence – Canada (Health Canada, LNHPD)

Texto original en inglés.

La fórmula vendida en Europa con el mismo nombre puede ser diferente. Esta información no sustituye el consejo de un médico o farmacéutico.

Lista en la revisión oficial del 8 de octubre de 2026 (registro: Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias).

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