IONITE APF FOAM- sodium fluoride aerosol, foam 
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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Castor Oil, Decyl Glucoside, Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Propellant A31, Sodium Benzoate, Sodium Laureth Sulface, Sodium Saccharne, Triethanolamine, Xylitol

Store at a controlled room temperature 59o-86oF (15o-30oC)

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IONITE APF  FOAM
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53045-252
Route of AdministrationDENTAL, TOPICAL, ORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5498 g  in 126 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
WATER (UNII: 059QF0KO0R)  
HYDROFLUORIC ACID (UNII: RGL5YE86CZ)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XYLITOL (UNII: VCQ006KQ1E)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
TROLAMINE (UNII: 9O3K93S3TK)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Mint Parfait) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53045-252-44126 g in 1 BOTTLE; Type 0: Not a Combination Product04/22/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/22/2013
Labeler - Dharma Research, inc. (078444642)
Registrant - Dharma Research, inc. (078444642)
Establishment
NameAddressID/FEIBusiness Operations
Dharma Research, inc.078444642manufacture(53045-252)

Revised: 10/2020
Document Id: 2d39144b-2d4c-47bf-8f4a-e40e0da8d24f
Set id: d22afac7-45d6-467e-951a-e7c241b9180d
Version: 3
Effective Time: 20201027
 
Dharma Research, inc.