Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 3.4 FL OZ (100mL) in plastic bottles. Mild Mint: NDC 0126-0289-92 STORAGE Store at Controlled Room Temperature, 68-77°F (20-25°C); PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label NDC 0126-0289-92 P9931143 Colgate ® PreviDent ® 5000 ppm Rx Only ORTHO DEFENSE 1.1% Sodium Fluoride for orthodontic patients PRESCRIPTION STRENGTH TOOTHPASTE contains TRI-CALCIUM PHOSPHATE mild mint 3.4 FL OZ (100 mL) PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
- HOW SUPPLIED 3.4 FL OZ (100mL) in plastic bottles. Mild Mint: NDC 0126-0289-92 STORAGE Store at Controlled Room Temperature, 68-77°F (20-25°C)
- PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label NDC 0126-0289-92 P9931143 Colgate ® PreviDent ® 5000 ppm Rx Only ORTHO DEFENSE 1.1% Sodium Fluoride for orthodontic patients PRESCRIPTION STRENGTH TOOTHPASTE contains TRI-CALCIUM PHOSPHATE mild mint 3.4 FL OZ (100 mL) PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
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. Active Ingredient Sodium fluoride 1.1% (w/w) Inactive Ingredients blue 1, cellulose gum, flavor, fumaric acid, hydrated silica, mica, poloxamer 338, PEG-12, sodium benzoate, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, tricalcium phosphate, water, xanthan gum
Indications & Usage
A dental caries preventive; for twice daily self-applied topical use. PreviDent® 5000 Ortho Defense™ 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice 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.)
Dosage & Administration
Follow these instructions unless otherwise instructed by your dental professional: 1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 Ortho Defense™ to a toothbrush. Brush teeth thoroughly twice daily for two minutes in place of your regular toothpaste. 2. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 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 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.
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.
Storage & Handling
STORAGE Store at Controlled Room Temperature, 68-77°F (20-25°C)
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