FDA Label for Sorbet Apf
View Indications, Usage & Precautions
Sorbet Apf Product Label
The following document was submitted to the FDA by the labeler of this product Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.. 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.
Indications & 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 & Administration
Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used a preventative caries treatment two times a year.
1. After thorough propylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth,
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Inactive Ingredient
Citric Acid, FD&C Green #3, FD&C Yellow #5 (tartrazine) as a color additive, Flavor, Manesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol
Storage And Handling
- Store at controlled room temperature 59-86 F (15-30 C)
- Protect from freezing
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