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

Entire Label

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

IONITE APF  FOAM
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53045-251
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 1.5498 g  in 126 g
Inactive Ingredients
Ingredient Name Strength
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     
Shape Size
Flavor GRAPE (Concord Grape) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53045-251-44 126 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/22/2013
Labeler - Dharma Research, inc. (078444642)
Registrant - Dharma Research, inc. (078444642)
Establishment
Name Address ID/FEI Business Operations
Dharma Research, inc. 078444642 manufacture(53045-251)

Revised: 4/2013
Document Id: f3d95782-692c-4e95-8860-5d3eb83f9fb3
Set id: 4828b482-486f-4105-bed0-3fe2ddbbddb1
Version: 1
Effective Time: 20130422
 
Dharma Research, inc.