Sodium Fluoride 5000 ppm Dry Mouth

Sodium Fluoride 5000 ppm Dry Mouth is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Sheffield Pharmaceuticals LLC taken by dental and marketed as a human prescription drug product. Identifiers on file: NDC 11527-755, label effective 20210302. It is one of 263 FDA drug label records sharing the active ingredient SODIUM FLUORIDE. 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 FLUORIDE are most often described in connection with: sodium fluoride, caries preventive, usage dental, daily self-applied, well established, extraordinarily effective, applied frequently, mouthpiece applicators. 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; for once daily self-applied topical use. 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 Dry Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze tube is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be 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 pediatric patients 6 years of age or older, apply a thin ribbon of Sodium Fluoride 5000 ppm Dry Mouth to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime, in place of your regular toothpaste. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, ages 6-16 years, expectorate after use and rinse mouth thoroughly.

CONTRAINDICATIONS: Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this product. Read directions carefully before using. Keep out of reach of infants and children.

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 263 drug label records with SODIUM FLUORIDE 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 Dry Mouth used for?
INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. 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 Dry Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze tube is easily applied onto a toothbrush. This …

Who makes Sodium Fluoride 5000 ppm Dry Mouth?
Sheffield Pharmaceuticals LLC is the labeler of record for Sodium Fluoride 5000 ppm Dry Mouth. 263 FDA label records share the active ingredient SODIUM FLUORIDE, 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 Dry Mouth 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 Dry Mouth 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 FLUORIDE?
Yes. 263 FDA drug label records list SODIUM FLUORIDE 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 Dry Mouth 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.