Label: IONITE APF FOAM- sodium fluoride aerosol, foam
- NDC Code(s): 53045-253-44
- Packager: Dharma Research, inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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:53045-253 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 STRAWBERRY (Strawberry Shortcake) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53045-253-44 126 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(53045-253)