Ionite APF description, usages, side effects, indications, overdosage, supplying and lots more!

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Ionite APF

Dharma Research, inc.
Dharma Research, inc.




FULL PRESCRIBING INFORMATION

  • Store at 59o - 86oF (15o - 30oC)
  • Protect from freezing
  • Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products


Citric Acid, FDandC Red No. 40 (C.I. 16035), 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

Ionite APF

Sodium Fluoride GEL

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53045-201
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 10.241 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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53045-201-17 490 in 1 BOTTLE
2 NDC:53045-201-08 245 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-01-01


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