FDA Label for Iris 60 Second Apf
View Indications, Usage & Precautions
Iris 60 Second Apf Product Label
The following document was submitted to the FDA by the labeler of this product Benco Dental. 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.
Active Ingredients:
1.23% Fluoride Ion
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.
Purpose:
Fluoride Treatment Gel
Indications And Usage:
• A stable thixotropic fluoride treatment gel used to help prevent dental decay.
• For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.
Warnings:
• Keep out of reach of children.
• Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
• Read directions carefully before using.
Dosage And Administration:
- Shake well before use. This is a one minute of four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year.
• After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
• Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
• Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Other Information:
Do not store above 25°C/77°F. Do not freeze.
Inactive Ingredients:
Citric Acid, FD&C Red #40, FD&C Yellow #5 (tartrazine) as a color additive, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol
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