Sodiumside effects
sodium fluoride 0.011 MG/MG Toothpaste [Dentagel]
Adverse reactions
Allergic reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 9, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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 gel, which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 9, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Contraindications
Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 9, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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