Potassium Nitrate

INDICATIONS AND USAGE:

A dental caries preventive and sensitive toothpaste; for twice daily self-applied topical use,following by rinsing, helps reduce the painful sensitivity of the teeth to cold, heat, acid, sweets or contact in adults patients and children 12 years of age and older.

1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze-tube is easily applied onto a toothbrush.

This prescription toothpaste should be used twice daily in place of your regular toothpaste, unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis.

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DOSAGE AND ADMINISTRATION:

Follow these instructions unless otherwise instructed by your dental professional: Adults and pediatric patients 12 years of age or older, apply at least a 1 inch strip of Sodium Fluoride 5000 ppm Sensitive onto a soft bristle toothbrush.

Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice daily, (morning and evening) or as recommended by dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age:consultant a dentist or physician.

ADVERSE REACTIONS:

Allergic reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Sheffield Pharmaceuticals, LLC. gov/medwatch.

CONTRAINDICATIONS:

Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.

Used for removing granulation tissue, warts (including verrucae), for cautery and as a caustic.

The tip is moistened with suitably clean water and applied topically to the area to be treated. Surrounding areas of healthy skin, etc. should be protected from the caustic/staining action of silver nitrate by a suitable barrier such as petroleum jelly, where necessary and practicable.

Skin and subcutaneous tissue disorders Chronic application of silver nitrate or its products to conjunctive, mucous membranes or open wounds may lead to a condition known as argyria, an accumulation of silver metal or compounds in the connective tissues which gives rise to a local or general bluish-black appearance.

This is thought to be a completely harmless cosmetic effect only, but it may persist indefinitely or disappear only very slowly. Absorption of nitrate following reduction of nitrate by certain bacteria in some wounds may cause methaemoglobinaemia.

There is a risk of electrolyte disturbances. Cases of either argyria or methaemoglobinaemia are very rare (<1/10,000) and are likely to arise only under exceptional circumstances of prolonged use of large quantities of sliver nitrate.

Paediatric population No data are available Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Hypersensitivity to the silver nitrate or to the excipient potassium nitrate. Not for use near the eyes or other sensitive areas of the body, due to the corrosive / staining action of the product. Should not be used for genital warts.