Your browser does not support JavaScript! IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]
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RxNorm Names

IONITE APF (sodium fluoride) gel
[Dharma Research, inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

  • 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, 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

Entire Label

IONITE APF 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:53045-207
Route of AdministrationDENTAL, TOPICAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION6.027 g  in 490 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorVANILLA (French Vanilla) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53045-207-17490 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2013
Labeler - Dharma Research, inc. (078444642)
Registrant - Dharma Research, inc. (078444642)
Establishment
NameAddressID/FEIBusiness Operations
Dharma Research, inc.078444642manufacture(53045-207)

Revised: 1/2013
 
Dharma Research, inc.

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