FDA Label for Gel 7 Neutral Topical Fluoride Gel Mint
View Indications, Usage & Precautions
Gel 7 Neutral Topical Fluoride Gel Mint 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
Gel 7 contains 2.0% sodium fluoride to supply 1.0% fluoride ion in a thixotropic gel base at pH 7.
Medicinal Ingredient:
1.0 % Fluoride ion
Non-Medicinal Ingredients:
Purified water, glycerin, potassium sorbate, methyl paraben, polysorbate 80, sodium saccharin, methyl salcylate, acrylic polymer, sodium hydroxide, xanthan gum, and flavouring agents.
Directions:
1. Shake well before using. 2. Fill Germiphene brand disposable gel trays to appropriate level. 3. After thorough prophylaxis, air dry teeth and insert trays for four minutes. 4. Remove trays and have patient expectorate excess gel.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Warning/Caution:
Do not eat, drink, or rinse for 30 minutes after treatment. Shake bottle vigorously before dispensing. Do not use if tamper-evident foil seal is broken. Do not store in direct sunlight.
Package Label.Principal Display Panel
450 mL (15.2 fl oz)
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