Recommended Use:
A topical anticaries preparation for professional dental use only.
Floam Topical Floam Fluoride
FDA Label NDC 61508-1120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Germiphene Corporation for the product Floam Topical Floam Fluoride (NDC 61508-1120). 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 recommended use:, otc - purpose, medicinal ingredients:, non-medicinal ingredients:, directions:, warning:, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
1.23% fluoride ion (from 1.69% sodium fluoride and 0.5% hydrogen fluoride) in a flavored base at pH 4.
Medicinal Ingredients:
1.23% fluoride ion.
Non-Medicinal Ingredients:
Water, glycerin, cocamidopropyl betaine, xylitol, phosphoric acid, flavouring agents, xanthan gum, polysorbate 20, poloxamer 407, sodium saccharin, PVP, sodium benzoate
Directions:
1. Use after thorough prophylaxis. 2. Shake prior to dispensing. 3. Place nozzle tip to applicator floor and press down on trigger to dispense foam. NOTE: Foam will expand to fill tray. 4. Immediately place trays in mouth and have patient bite down lightly for one minute. 5. Remove trays and have patient expectorate excess.
Warning:
Do not eat, drink, or rinse for 30 minutes after treatment. Do not puncture or incinerate container or store at temperatures over 50°C. Do not use in presence of open flame or spark. Contents under pressure; do not place in hot water or near any sources of heat.
Otc - Keep Out Of Reach Of Children
Kep out of reach of children.
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