FDA Label for 60 Second Gel Mint
View Indications, Usage & Precautions
60 Second 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 Or Purpose:
A topical APF anticaries preparation for dental use only.
Otc - Purpose
1.23% fluoride ion from sodium fluoride and hydrofluoric acid. Optimized low pH for a complete fluoride treatment in 60 seconds.
Medicinal Ingredient:
1.23% fluoride ion
Non-Medicinal Ingredients:
Water, glycerin, sodium saccharin, methyl paraben, potassium sorbate, phosphoric acid, hydrofluoric acid, acrylic polymer, silicon dioxide, zanthan gum, polysorbate 80 & flavoring agents.
Directions:
Shake well before using. Fill Germiphene brand disposable trays to appropriate level. After prophylaxis, air dry teeth and insert trays for one minute. 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. Do not use if tamper-evident seal is broken. Do not store in direct sunlight.
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