Label: AP-24- sodium fluoride mouthwash
- NDC Code(s): 62839-1152-1
- 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 Ingredient
- Purpose
- Use
- Warning
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Directions
- Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste.
- Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out.
- Do not swallow the rinse.
- Do not eat or drink for 30 minutes after rinsing.
- Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
- Supervise children as necessary until capable of using without supervision.
- Children under 6 years of age: Consult a dentist or doctor.
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Inactive Ingredients
Water (Aqua), Sorbitol, Glycerin, Poloxamer 338,1 Poloxamer 407,1 Dimethicone,1 Sodium Phosphate, Phosphoric Acid, Disodium EDTA, Sodium Saccharin, Sodium Benzoate, Flavor (Aroma).
- 1
- 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 and helps reduce plaque buildup.
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- PRINCIPAL DISPLAY PANEL - 500 ml Bottle Label
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INGREDIENTS AND APPEARANCE
AP-24
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-1152 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) Glycerin (UNII: PDC6A3C0OX) Poloxamer 338 (UNII: F75JV2T505) Poloxamer 407 (UNII: TUF2IVW3M2) Dimethicone (UNII: 92RU3N3Y1O) Sodium Phosphate (UNII: SE337SVY37) Phosphoric Acid (UNII: E4GA8884NN) Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM) Saccharin Sodium (UNII: SB8ZUX40TY) Sodium Benzoate (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-1152-1 500 mL in 1 BOTTLE; 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)