Label: AP-24 FLUORIDE- sodium monofluorophosphate paste
- NDC Code(s): 62839-1151-1
- Packager: NSE Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 10, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Use
- Warning
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Directions
- Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
- Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
- Supervise children as necessary until capable of using without supervision.
- Children under 2 years of age: Consult a dentist or doctor.
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Inactive Ingredients
Dicalcium Phosphate Dihydrate, Water (Aqua), Sorbitol, Glycerin, Dimethicone,1 Poloxamer 338,1 Poloxamer 407,1 Cellulose Gum, Sodium Lauryl Sulfate, Flavor (Aroma), Sodium Saccharin, Titanium Dioxide (CI 77891).
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- AP-24,® the patented ultra-emulsion of medical grade, high molecular weight Dimethicone and the surfactants Poloxamer 338 and Poloxamer 407, helps to remove plaque during brushing and helps reduce plaque buildup.
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- PRINCIPAL DISPLAY PANEL - 170 g Tube Label
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INGREDIENTS AND APPEARANCE
AP-24 FLUORIDE
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-1151 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 8.6 mg in 1 g Inactive Ingredients Ingredient Name Strength DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) Dimethicone (UNII: 92RU3N3Y1O) Poloxamer 338 (UNII: F75JV2T505) Poloxamer 407 (UNII: TUF2IVW3M2) Glycerin (UNII: PDC6A3C0OX) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) Sodium Lauryl Sulfate (UNII: 368GB5141J) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Titanium Dioxide (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-1151-1 170 g in 1 TUBE; Type 0: Not a Combination Product 05/08/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 05/08/2017 Labeler - NSE Products, Inc. (803486393)