IONITE APF NEUTRAL- sodium fluoride gel
Dharma Research, inc.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
- Store at 59o — 86o F (15o — 30o C)
- Protect from freezing
- Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products
Citric Acid, Flavor, Hydrofluoric Acid, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xantham Gum, Xylitol.
- Keep out of the 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.
- Do not use on patients with an allergy Fluoride.
- For professional use only.
- Shake well before use.
- This is a four minute or one minute Fluoride gel for in-office patient use.
- For best results, use at least 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
| IONITE APF
sodium fluoride gel
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:53045-237 |
|Route of Administration ||DENTAL, TOPICAL, ORAL ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|SODIUM FLUORIDE (FLUORIDE ION) ||FLUORIDE ION ||4.41 g in 490 g |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| ANHYDROUS CITRIC ACID || |
| HYDROFLUORIC ACID || |
| magnesium aluminum silicate || |
| PHOSPHORIC ACID || |
| polysorbate 20 || |
| POTASSIUM HYDROXIDE || |
| water || |
| SODIUM BENZOATE || |
| SACCHARIN SODIUM || |
| TITANIUM DIOXIDE || |
| .ALPHA.-TOCOPHEROL ACETATE, DL- || |
| XANTHAN GUM || |
| XYLITOL || |
|Product Characteristics |
|Color || ||Score || |
|Shape || ||Size || |
|Flavor ||VANILLA (French Vanilla) ||Imprint Code || |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:53045-237-17 ||490 g in 1 BOTTLE ||None |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|unapproved drug other || ||01/01/2013 || |
|Labeler — Dharma Research, inc.
|Registrant — Dharma Research, inc. (078444642) |
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Dharma Research, inc. || ||078444642 ||manufacture (53045-237) |
Revised: 02/2013 Dharma Research, inc.
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