Wentworth Alcohol Free

Wentworth Alcohol Free 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 11527-735, label effective 20210323. 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: dental caries, sodium fluoride, weekly self-applied, solution protects, pediatric patients, rinse provides, ready-to-use preparation, convenient administration. 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 weekly self-applied topical use. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in adults and pediatric patients. Wentworth Sodium Fluoride Rinse provides a ready-to-use preparation for convenient administration and favorable compliance. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

DOSAGE AND ADMINISTRATION For caries — Adults and pediatric patients over age 6 years, 2 teaspoons (10 mL). Once a week, preferably at bedtime after thoroughly brushing the teeth, rinse vigorously around and between the teeth for one minute, then expectorate. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes afterwards.

CONTRAINDIACTIONS Do not use in patients with dysphagia. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

WARNINGS Keep out of reach of infants and children. Pediatric patients under age 12 should be supervised in the use of this product. Patients under age 6 require special supervision to prevent repeated swallowing of rinse since they frequently swallow significant amounts while rinsing. Prolonged daily ingestion may result in dental fluorosis in patients under age 6, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING

ADVERSE REACTIONS In patients with mucositis, gingival tissues may be hypersensitive to flavor present in formulation. Allergic reactions and other idiosyncrasies are rarely reported.

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 Wentworth Alcohol Free used for?
INDICATIONS AND USAGE A dental caries preventive, for weekly self-applied topical use. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in adults and pediatric patients. Wentworth Sodium Fluoride Rinse provides a ready-to-use preparation for convenient administration and favorable compliance. May be used in areas where drinking water is fluoridated since …

Who makes Wentworth Alcohol Free?
Sheffield Pharmaceuticals LLC is the labeler of record for Wentworth Alcohol Free. 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 Wentworth Alcohol Free 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 Wentworth Alcohol Free 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 Wentworth Alcohol Free 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.