Sodium Fluoride 5000 ppm Enamel Protect

Sodium Fluoride 5000 ppm Enamel Protect is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%. It is labelled by Sheffield Pharmaceuticals LLC taken by dental and marketed as a human prescription drug product. Identifiers on file: NDC 11527-745, label effective 20210104. It is one of 2 FDA drug label records sharing the active ingredient SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5% are most often described in connection with: sodium fluoride, caries preventive, twice daily, usage dental, sensitive teeth, self-applied topical, followed rinsing, helps reduce. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE: A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, 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 Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a 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 in used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional: Adults and children 12 years of age and older: Apply at least a 1 inch strip of Sodium Fluoride 5000 ppm Enamel Protect onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice a day (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: Consult a dentist or physician.

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

WARNINGS: Not for systemic treatment- DO NOT SWALLOW. Keep out of the reach of infants and 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: 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.

FDA lists 2 drug label records with SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5% as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Sodium Fluoride 5000 ppm Enamel Protect used for?
INDICATIONS AND USAGE: A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, 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 …

Who makes Sodium Fluoride 5000 ppm Enamel Protect?
Sheffield Pharmaceuticals LLC is the labeler of record for Sodium Fluoride 5000 ppm Enamel Protect. 2 FDA label records share the active ingredient SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Sodium Fluoride 5000 ppm Enamel Protect come in?
administered by dental. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Sodium Fluoride 5000 ppm Enamel Protect prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%?
Yes. 2 FDA drug label records list SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5% as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Sodium Fluoride 5000 ppm Enamel Protect been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.