SODIUM FLUORIDE 5000 PPM FRUIT
(+1 other brands)
Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied 3.4 FLOZ (100ml) NET WT. Tube NDC #11527-730-44 FRUIT 3.4 FLOZ (100ml) NET WT. Tube NDC #11527-750-43 SPEARMINT STORAGE: Store at Controlled Room Temperature, 20-25°C (68-77°F).; PRINCIPAL DISPLAY PANEL - 100ml Tube Wentworth NDC 11527-750-43 Rx only SODIUM FLUORIDE 5000 ppm SPEARMINT 1.1% Sodium Fluoride Prescription Strength Toothpaste NET WT. 3.4 FLOZ. (100ml) Wentworth Spearmint Tube.jpg; PRINCIPAL DISPLAY PANEL - 100ml Carton Wentworth NDC 11527-750-43 Rx only Sodium Fluoride 5000 ppm SPEARMINT 1.1% Sodium Fluoride Prescription Strength toothpaste NET WT 3.4FLOZ (100ml) 544202-SH00147_Carton.jpg; PRINCIPAL DISPLAY PANEL - 100ml Tube Wentworth NDC 11527-730-44 Rx Only Sodium Fluoride 5000 ppm FRUI T 1.1% Sodium Fluoride Prescription Toothpaste 3.4 FLOZ (100ml) Wentworth Fruit Tube.jpg; PRINCIPAL DISPLAY PANEL - 100ml Carton Wentworth NDC 11527-730-44 Sodium Fluoride 5000 ppm Rx Only 1.1% Sodium Fluoride Prescription Toothpaste FRUIT 3.4 FLOZ (100ml) 544200-SH00146_Fruit_Carton.jpg
- How Supplied 3.4 FLOZ (100ml) NET WT. Tube NDC #11527-730-44 FRUIT 3.4 FLOZ (100ml) NET WT. Tube NDC #11527-750-43 SPEARMINT STORAGE: Store at Controlled Room Temperature, 20-25°C (68-77°F).
- PRINCIPAL DISPLAY PANEL - 100ml Tube Wentworth NDC 11527-750-43 Rx only SODIUM FLUORIDE 5000 ppm SPEARMINT 1.1% Sodium Fluoride Prescription Strength Toothpaste NET WT. 3.4 FLOZ. (100ml) Wentworth Spearmint Tube.jpg
- PRINCIPAL DISPLAY PANEL - 100ml Carton Wentworth NDC 11527-750-43 Rx only Sodium Fluoride 5000 ppm SPEARMINT 1.1% Sodium Fluoride Prescription Strength toothpaste NET WT 3.4FLOZ (100ml) 544202-SH00147_Carton.jpg
- PRINCIPAL DISPLAY PANEL - 100ml Tube Wentworth NDC 11527-730-44 Rx Only Sodium Fluoride 5000 ppm FRUI T 1.1% Sodium Fluoride Prescription Toothpaste 3.4 FLOZ (100ml) Wentworth Fruit Tube.jpg
- PRINCIPAL DISPLAY PANEL - 100ml Carton Wentworth NDC 11527-730-44 Sodium Fluoride 5000 ppm Rx Only 1.1% Sodium Fluoride Prescription Toothpaste FRUIT 3.4 FLOZ (100ml) 544200-SH00146_Fruit_Carton.jpg
Overview
Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.
Indications & 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.)
Dosage & Administration
: Follow these instructions unless otherwise instructed by your dental professional: Adults and pediatric patients 6 years of age or older, apply a thin ribbon of Sodium Fluoride 5000 ppm to a toothbrush. Brush thoroughly once daily for at least two minutes, preferably at bedtime. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, ages 6-16, expectorate after use and rinse mouth thoroughly.
Warnings & Precautions
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.
Contraindications
: Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
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.
Storage & Handling
STORAGE: Store at Controlled Room Temperature, 20-25°C (68-77°F).
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