Description:
Topical neutral 1.1% sodium fluoride for use as a dental caries preventative in children and adults. This prescription product is not a dentifrice.
Fluorishield
FDA Label NDC 10733-130
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medical Products Laboratories, Inc. for the product Fluorishield (NDC 10733-130). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description:, warnings:, overdose:, caution:, custom carriers or trays, brush on, overdentures, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings:
DO NOT SWALLOW. As with all medications, this product should be kept out of reach of children.
Overdose:
Accidental ingestion of a usual treatment dose (1-2mgF) is not harmful.
Caution:
Federal (U.S.A.) law prohibits dispensing without a prescription.
Custom Carriers Or Trays
Brush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Add one drop of FluoriShield into each tooth area in the custom carrier and spread evenly with the applicator tip of the fluoride bottle. Place carriers over the teeth and let it remain in place for one (1) minute or longer (as directed by your doctor). Expectorate the excess gel. Clean carriers with cold water. Spit out the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.
Tray (Fluorishield 1)
Brush On
Brush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Apply a thin ribbon of gel to the toothbrush and spread evenly with the applicator tip of the fluoride bottle. Brush all tooth surfaces and allow fluoride to remain in place for one (1) minute or longer (as directed by your doctor). Clean carriers with cold water. Expectorate the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.
Brush (Fluorishield 2)
Overdentures
Brush all tooth surfaces. Clean your dentures. Adults and children 6 years of age or older: Apply one (1) or two (2)drops of FluoriShield to each tooth area in your denture and place the dentures in your mouth. Leave in place for one (1) minute or longer (as directed by your doctor).Expectorate the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.
Denture (Fluorishield 3)
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