Label: IONITE APF- sodium fluoride gel
- NDC Code(s): 53045-207-17
- Packager: Dharma Research, inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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- STORAGE AND HANDLING
- Store at 59o - 86oF (15o - 30oC)
- Protect from freezing
- Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products
- INACTIVE INGREDIENT
Citric Acid, 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.
- WARNINGS AND PRECAUTIONS
- 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.
- INSTRUCTIONS FOR USE
- 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
- INGREDIENTS AND APPEARANCE
sodium fluoride gel
Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53045-207 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 VANILLA (French Vanilla) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53045-207-17 490 g in 1 BOTTLE 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. (078444642) Registrant - Dharma Research, inc. (078444642) Establishment Name Address ID/FEI Business Operations Dharma Research, inc. 078444642 manufacture(53045-207)