FDA Label for Floam Topical Floam Fluoride
View Indications, Usage & Precautions
Floam Topical Floam Fluoride Product Label
The following document was submitted to the FDA by the labeler of this product Germiphene Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Recommended Use:
A topical anticaries preparation for professional dental use only.
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.
* Please review the disclaimer below.
