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.

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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 Type HUMAN PRESCRIPTION DRUG 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 (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 6.027 g  in 490 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
HYDROFLUORIC ACID (UNII: RGL5YE86CZ)  
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)

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.