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.

----------


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.

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
Document Id: a662954e-0102-419f-add4-e05b4f865e36
Set id: e6c31330-43e0-4d32-af54-ff852af39cab
Version: 1
Effective Time: 20130101
 
Dharma Research, inc.