Sodium Fluoride 5000 ppm Fruit
Generic: SODIUM FLUORIDE
Basic Information
Manufacturer
Sheffield Pharmaceuticals LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
DENTAL
FDA Set ID
a73f72b9-dbcd-4eed-9c20-46a9e8daf859
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 dental cream 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush.
This prescription dental cream should be used once daily in place of your regular toothpaste, unless otherwise instructed by your dental professional.
May be used whether or not 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 dental cream 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush.
This prescription dental cream should be used once daily in place of your regular toothpaste, unless otherwise instructed by your dental professional.
May be used whether or not 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 can not perform the brushing process without significant swallowing.
Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental cream, which could cause dental fluorosis.
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 dental cream, which could cause dental fluorosis.
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 Sheffield Pharmaceuticals, LLC at 1-800-222-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.