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| Product NDC Code | 53045-201 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Ionite apf |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | DENTAL, ORAL | ||||||||
| Dosage Form | GEL | ||||||||
| RxCUI drug identifier | 245593 | ||||||||
| Labeler Name | Dharma Research, inc. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Citric Acid, FD & C Red No. 40 (C.I. 16035), Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xanthan Gum, Xylitol
Spl product data elements
Usually a list of ingredients in a drug product.Ionite APF Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION CITRIC ACID MONOHYDRATE FD&C RED NO. 40 MAGNESIUM ALUMINUM SILICATE PHOSPHORIC ACID POLYSORBATE 20 WATER SODIUM BENZOATE SACCHARIN SODIUM TITANIUM DIOXIDE .ALPHA.-TOCOPHEROL ACETATE, DL- XANTHAN GUM XYLITOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.20200415_201_08_RevB 20200415_201_17_RevB 20200415_201_38_RevB
Instructions for use
Information about safe handling and use of the drug product.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
Storage and handling
Information about safe storage and handling of the drug product.Store at 59 o - 86 o F (15 o - 30 o C) Protect from freezing Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API