FDA records indicate that there are no current recalls for this drug.
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Ctx4 Gel 5000 Mint Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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)
History
There is currently no drug history available for this drug.
Other Information
Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in adults and pediatric patients.
Sources
Ctx4 Gel 5000 Mint Manufacturers
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Oral Biotech
Ctx4 Gel 5000 Mint | Oral Biotech
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.
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