CTx4 Gel 5000 Mint Sodium fluoride GLYCERIN HYDRATED SILICA MALTITOL TRIBASIC CALCIUM PHOSPHATE HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) MENTHOL POLYSORBATE 20 POTASSIUM SORBATE SACCHARIN SODIUM BENZOATE SODIUM BICARBONATE SODIUM HYDROXIDE SODIUM LAURYL SULFATE WATER XYLITOL SODIUM FLUORIDE FLUORIDE ION opaque CTx4 Gel 5000 Citrus Sodium fluoride GLYCERIN HYDRATED SILICA MALTITOL TRIBASIC CALCIUM PHOSPHATE HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) POLYSORBATE 20 POTASSIUM SORBATE SACCHARIN SODIUM BENZOATE SODIUM BICARBONATE SODIUM HYDROXIDE SODIUM LAURYL SULFATE WATER XYLITOL SODIUM FLUORIDE FLUORIDE ION opaque
Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied: 2 oz (56.699g) tube. NDC# 61578-205-01 (Mint) NDC# 61578-206-01 (Citrus); CTx4 Gel 5000 Mint and Citrus enclosure and carton labels: Tube Principle Display Panel Box Principle Display Panel Tube Principle Display Panel Box Principle Display Panel
- How Supplied: 2 oz (56.699g) tube. NDC# 61578-205-01 (Mint) NDC# 61578-206-01 (Citrus)
- CTx4 Gel 5000 Mint and Citrus enclosure and carton labels: Tube Principle Display Panel Box Principle Display Panel Tube Principle Display Panel Box Principle Display Panel
Overview
Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in adults and pediatric patients.
Indications & Usage
Indications and Use: A dental caries preventive; for once daily self-applied topical use. It is well established that a 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 CariFree CTx4 Gel 5000 brand of 1.1% sodium fluoride toothpaste in a squeeze tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a 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. After brushing with toothpaste, adults and pediatric patients 6 years of age and older, apply a thin ribbon of gel to the teeth with a toothbrush for at least one minute, preferably at bedtime. 2. Adult patients, expectorate gel after use. For best results, do not eat, drink or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate gel 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 water fluoridation exceeds 0.6 ppm. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel. 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, 20-25° C (68-77°F)
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