IONITE APF- 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, FDandC Blue No. 1 (C.I. 42090), ,Flavor, Hydrofluoric Acid, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xanthan 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.
- Ionite APF Gel contains artificial color, confirm that no kno.wn patient allergies exist.
- 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:53045-203 |
|Route of Administration ||DENTAL, TOPICAL, ORAL ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|SODIUM FLUORIDE (FLUORIDE ION) ||FLUORIDE ION ||6.027 g in 490 g |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| WATER || |
| MAGNESIUM ALUMINUM SILICATE || |
| FD&C RED NO. 40 || |
| SACCHARIN SODIUM || |
| SODIUM BENZOATE || |
| TITANIUM DIOXIDE || |
| XYLITOL || |
| ANHYDROUS CITRIC ACID || |
| .ALPHA.-TOCOPHEROL ACETATE, DL- || |
| XANTHAN GUM || |
| CARBOMER HOMOPOLYMER TYPE C || |
| PHOSPHORIC ACID || |
| HYDROFLUORIC ACID || |
|Product Characteristics |
|Color || ||Score || |
|Shape || ||Size || |
|Flavor ||MARSHMALLOW ||Imprint Code || |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:53045-203-17 ||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 (53045-203) |
Revised: 01/2013 Dharma Research, inc.
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