Label: IONITE APF FOAM- sodium fluoride aerosol, foam
- NDC Code(s): 53045-250-44
- Packager: Dharma Research, inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated April 22, 2013
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- INACTIVE INGREDIENT
Castor Oil, Decyl Glucoside, Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Propellant A31, Sodium Benzoate, Sodium Laureth Sulface, Sodium Saccharne, Triethanolamine, XylitolClose
- WARNINGS AND PRECAUTIONS
- Do not swallow.
- Keep out of reach of children.
- Contents under pressure.
- Do not place in hot water or near radiators, stoves or other sources of heat.
- Do not puncture or incinerate container. Do not spray towards open flames.
- For professional use only.
- INSTRUCTIONS FOR USE
- Remove cap from can. Prior to each use, shake can thoroughly for at least 15 seconds.
- To dispense,invert the can completely upside down. Slowly depress nozzle to dispense foam into a fluoride tray (foam will expand slightly higher than fluoride tray).
- Air dry teeth thoroughly and inset tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth between 1 - 4 minutes.
- Use a saliva ejector during treatment to minimize ingestion of product.
- Remove the tray(s) and have patient expectorate.
- Instruct patient not to eat, drink or rinse for 30 minutes after treatment.
- STORAGE AND HANDLING
Store at a controlled room temperature 59o-86oF (15o-30o C)Close
- INGREDIENTS AND APPEARANCE
IONITE APF FOAM
sodium fluoride aerosol, foam
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53045-250 Route of Administration DENTAL, TOPICAL, ORAL 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 BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53045-250-44 126 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(53045-250)