Sodium Fluoride 5000 PPM
Generic: SODIUM FLUORIDE
Basic Information
Manufacturer
Westminster Pharmaceuticals, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
DENTAL
FDA Set ID
56efb346-c715-463d-9260-f7fcfbd2b70f
Indications & Usage
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 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.)
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.)
Warnings
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.
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
ADVERSE REACTIONS 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.
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.