- Active Ingredient
- Purpose
- Indications and Usage
- Warnings
-
Dosage and Administration
Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year.
1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PURELIFE APF
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68987-011 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 5.6 g in 454 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PHOSPHORIC ACID (UNII: E4GA8884NN) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) XYLITOL (UNII: VCQ006KQ1E) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color green Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68987-011-15 454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/18/2012 Labeler - PureLife Dental (828690904)