SF 5000 Plus
Generic: 1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL CREAM
Basic Information
Manufacturer
Cypress Pharmaceutical, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
DENTAL
FDA Set ID
fa625ece-d873-491a-8d45-2833b64e5425
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 SF 5000 Plus brand of 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 SF 5000 Plus brand of 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 cannot perform the brushing process without significant swallowing .
Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of the dental cream which could cause dental fluorosis.
Read directions carefully before using.
If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning.
KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.
IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of the dental cream which could cause dental fluorosis.
Read directions carefully before using.
If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning.
KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.
IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Adverse Reactions
ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported.