PreviDent 5000 Dry Mouth
Generic: SODIUM FLUORIDE
Basic Information
Manufacturer
Colgate Oral Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
DENTAL
FDA Set ID
d93ee76f-454b-40bf-9357-39a2ae3b6ccb
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 PreviDent ® 5000 Dry Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze bottle 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.)
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 PreviDent ® 5000 Dry Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze bottle 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.)
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.