Label: SCOTTS SELECT APF FOAM FLUORIDE- sodium fluoride aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 69638-067-44 - Packager: Scotts 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 3, 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
- Warnings
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Directions
- 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 a fluoride tray (foam will expand slightly higher than fluoride 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 between 1 - 4 minutes.
- Use a saliva ejector during treatment to minimize ingestion of product.
- Remove tray(s) and have patient expectorate.
- Instruct patient not to eat, drink or rinse for 30 minutes after treatment.
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 130 mL Bottle Label
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INGREDIENTS AND APPEARANCE
SCOTTS SELECT APF FOAM FLUORIDE
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69638-067 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 0.0123 g in 1 mL Inactive Ingredients Ingredient Name Strength CASTOR OIL (UNII: D5340Y2I9G) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) WATER (UNII: 059QF0KO0R) HYDROFLUORIC ACID (UNII: RGL5YE86CZ) PHOSPHORIC ACID (UNII: E4GA8884NN) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XYLITOL (UNII: VCQ006KQ1E) POLOXAMER 407 (UNII: TUF2IVW3M2) TROLAMINE (UNII: 9O3K93S3TK) Product Characteristics Color Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69638-067-44 130 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/22/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/22/2013 Labeler - Scotts Dental Supply LLC (137217043)