Label: IONITE APF- sodium fluoride gel
- NDC Code(s): 53045-206-08, 53045-206-17
- Packager: Dharma Research, inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 16, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
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WARNINGS AND PRECAUTIONS
- Keep out of the 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.
- Do not use on patients with an allergy Fluoride.
- Ionite APF Gel contains artificial color, confirm that no kno.wn patient allergies exist.
- For professional use only.
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INSTRUCTIONS FOR USE
- Shake well before use.
- This is a four minute or one minute Fluoride gel for in-office patient use.
- For best results, use at least twice a year.
- After thorough prophylaxis, fill two single or one dual tray one third full with gel. Air dry teeth and insert trays into the mouth.
- Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness)
- Remove trays, instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IONITE APF
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53045-206 Route of Administration DENTAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 6.027 g in 490 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PHOSPHORIC ACID (UNII: E4GA8884NN) POLYSORBATE 20 (UNII: 7T1F30V5YH) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) XANTHAN GUM (UNII: TTV12P4NEE) XYLITOL (UNII: VCQ006KQ1E) 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:53045-206-17 490 g in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2013 2 NDC:53045-206-08 245 g in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2013 Labeler - Dharma Research, inc. (078444642) Registrant - Dharma Research, inc. (078444642) Establishment Name Address ID/FEI Business Operations Dharma Research, inc. 078444642 manufacture(53045-206)
