Label: PURELIFE APF- sodium fluoride aerosol, foam
- NDC Code(s): 68987-024-12
- Packager: PureLife Dental
- Category: HUMAN PRESCRIPTION DRUG LABEL
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.
Drug Label Information
Updated May 14, 2014
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient:
- Purpose:
- Indications and Usage:
- Warnings:
-
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
-
INGREDIENTS AND APPEARANCE
PURELIFE APF
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68987-024 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:68987-024-12 125 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)