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, F D & C 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.

205

IONITE APF 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53045-205
Route of AdministrationDental, TOPICAL, ORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION6.027 g  in 490 g
Inactive Ingredients
Ingredient NameStrength
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 (UNII: 9E8X80D2L0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
HYDROFLUORIC ACID (UNII: RGL5YE86CZ)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53045-205-17490 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2013
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(53045-205)

Revised: 2/2021
Document Id: dd3dc685-7167-463c-8752-aa9f2ac2dad3
Set id: ab9b07ad-f6b2-4289-bec4-fec58270dc97
Version: 2
Effective Time: 20210220
 
Dharma Research, Inc.