Label: PURELIFE APF- sodium fluoride gel
- NDC Code(s): 68987-011-15
- Packager: PureLife Dental
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status:
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 December 18, 2017
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- Active Ingredient
Fluoride Ion 1.23%.
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.Close
Fluoride Treatment GelClose
- Indications and Usage
- A stable thixotropic fluoride treatment gel used to help prevent dental decay.
- For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.
- Keep out of reach of children.
- Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
- Read directions carefully before using.
- 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 two times a year.
1. After thorough prophylaxis, fill two single or one dual try, 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.Close
- Other Information
Do not store above 25°C/77°F. Do not freeze.Close
- Inactive Ingredients
Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green #3, red #3, yellow #5 (tartrazine), as a color additive.Close
- INGREDIENTS AND APPEARANCE
sodium fluoride gel
Product 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) 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)