IONITE APF NEUTRAL- 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, FD & C Green No. 3 (C.I. 42053), FD & C Yellow No. 5 (C.I. 19140), Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xantham Gum, Xylitol

IMG

IONITE APF  NEUTRAL
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53045-235
Route of AdministrationDENTAL, ORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION4.41 g  in 490 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Mint Parfait) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53045-235-17490 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(53045-235)

Revised: 11/2020
Document Id: 5d289e00-80ff-4403-8fdf-780b2d932efb
Set id: ad7a660b-274c-417e-bdf3-1d5addf06ad1
Version: 3
Effective Time: 20201118
 
Dharma Research, inc.