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 TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:53045-252
Route of AdministrationDENTAL, TOPICAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5498 g  in 126 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
DECYL GLUCOSIDE 
WATER 
HYDROFLUORIC ACID 
PHOSPHORIC ACID 
SODIUM BENZOATE 
SODIUM LAURETH SULFATE 
SACCHARIN SODIUM 
XYLITOL 
POLOXAMER 407 
TROLAMINE 
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
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: 4/2013
Document Id: 3f553fd8-38b6-4bf8-b816-cb6085a61866
Set id: d22afac7-45d6-467e-951a-e7c241b9180d
Version: 1
Effective Time: 20130422
 
Dharma Research, inc.