- Active Ingredient:
- Purpose:
- Indications and Usage:
- Warnings:
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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 fluoride tray (foam will expand slightly higher than the tray).
- Air dry teeth thoroughly and insert tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth for 1-4 minutes.
- Use a saliva ejector during treatment to minimize ingestion of the product.
- Remove tray(s) and have patient expectorate.
- Instruct patient not to eat, drink or rinse for 30 minutes after treatment.
- Inactive Ingredients
- Other Information:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PURELIFE APF
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68987-021 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5375 g in 125 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) HYDROFLUORIC ACID (UNII: RGL5YE86CZ) PHOSPHORIC ACID (UNII: E4GA8884NN) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TROLAMINE (UNII: 9O3K93S3TK) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color white Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68987-021-12 125 g in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/27/2013 Labeler - PureLife Dental (828690904)