Label: SODIUM FLUORIDE 5000 PPM- sodium fluoride paste

Rx Only

1.1% Sodium fluoride
Prescription Strength Toothpaste

Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

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 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription 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.)

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

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.

Allergic reactions and other idiosyncrasies have been rarely reported.

To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) has been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose (a thin ribbon) of Sodium Fluoride 5000 ppm contains 2.5 mg fluoride. A 3.4 FL OZ tube (100 mL) contains approximately 605 mg fluoride.

Follow these instructions unless otherwise instructed by your dental professional:

1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of Sodium Fluoride 5000 ppm to a toothbrush. Brush teeth thoroughly once daily for at least two minutes, preferably at bedtime, in place of your regular toothpaste.
2. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.

1. Accepted Dental Therapeutics, Ed. 40, ADA, Chicago. P. 405-407, 1984.
2. Englander, HR, Keyes et al:JADA 75: 638-644, 1967.
3. Englander, HR, et al:JADA 78: 783-787, 1969.
4. Englander, HR, et al:JADA 83: 354-358, 1971.

Manufactured for:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217
Rev. 01/23

SPEARMINT
NDC 69367-311-01
Rx Only

Sodium Fluoride 5000 ppm
1.1% Sodium Fluoride Prescription Strength Toothpaste

3.4 FL OZ (100 mL)

Westminster
Pharmaceuticals

FRUITY
NDC 69367-312-01
Rx Only

Sodium Fluoride 5000 ppm
1.1% Sodium Fluoride Prescription Strength Toothpaste

3.4 FL OZ (100 mL)

Westminster
Pharmaceuticals