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SF 5000 Plus
  • Professionals
  • FDA PI

SF 5000 Plus

Generic name:sodium fluoride
Dosage form: dental cream
Drug class:Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Jun 21, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

SF 5000 Plus Description

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


ACTIVE INGREDIENTS:
Sodium Fluoride USP 1.1% (w/w)

INACTIVE INGREDIENTS: Purified Water, Sorbitol, Hydrated Silica, Glycerin, Tetrapotassium Pyrophosphate, Flavor, PEG 12, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Saccharin, Titanium Dioxide, FD&C Blue No. 1.

SF 5000 Plus - Clinical Pharmacology

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.

Indications and Usage for SF 5000 Plus

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.)

Contraindications

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

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 proces..