Label: SCOTTS SELECT NEUTRAL APF FLUORIDE- sodium fluoride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69638-157-16 - Packager: Scott's Dental Supply LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated March 12, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- DESCRIPTION
- Use
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Warnings
- 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 immediately.
- Do not use on patients with an allergy to fluoride.
- Scott's APF Gel contains artificial color, confirm that no known patient allergies exist.
- For professional use only.
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Directions
- Shake well before use.
- This is a four 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 four minutes.
- Remove trays, instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
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INGREDIENTS AND APPEARANCE
SCOTTS SELECT NEUTRAL APF FLUORIDE
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69638-157 Route of Administration DENTAL, TOPICAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.02 g in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) HYDROFLUORIC ACID (UNII: RGL5YE86CZ) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PHOSPHORIC ACID (UNII: E4GA8884NN) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) 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) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color GREEN Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69638-157-16 500 mL 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 - Scott's Dental Supply LLC (137217043)
