Label: AP-24- sodium fluoride mouthwash

  • 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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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

  • Purpose

    anticavity

  • Use

    Aids in the prevention of dental cavities.

  • Warning

    • Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    • Do not use if saftey seal is broken.
  • 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.
  • 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.
  • Questions?

    1-888-742-7626

  • PRINCIPAL DISPLAY PANEL - 500 ml Bottle Label

    AP24®

    Anti-Plaque
    Fluoride
    Mouthwash

    NU SKIN®

    500 ml e (16.9 Fl. Oz.)

    PRINCIPAL DISPLAY PANEL - 500 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    AP-24 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-1152
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-1152-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35505/08/2017
    Labeler - NSE Products, Inc. (803486393)
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