Sodium Fluoride 5000 ppm Sensitive

Generic: SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%

Prescription DrugDENTAL

Drug Information

Brand Name
Sodium Fluoride 5000 ppm Sensitive
Generic Name
SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%
Manufacturer
Sheffield Pharmaceuticals LLC
Product Type
Prescription Drug
Route
DENTAL
Application Number
02f4cf0b-188c-4522-b759-ffe4a9d150e8

Indications & Usage

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. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 Sodium Fluoride 5000 ppm Sensitive 1.1% sodium...

Read full indications

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. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 Sodium Fluoride 5000 ppm Sensitive 1.1% 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. (See WARNINGS for exception.)

Warnings

WARNINGS: Not for systemic treatment- Do not Swallow. Keep out of the reach of children. Children under 12 years of age, consult a dentist or physician. Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

Adverse Reactions

ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Sheffield Pharmaceuticals, LLC. at 1-800-222-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.