Label: AP-24 WHITENING- sodium monofluorophosphate paste

  • 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 October 20, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Sodium Monofluorophosphate 0.76% (0.15% w/v fluoride ion)

  • Purpose

    anticavity

  • Use

    Aids in the prevention of dental cavities.

  • Warning

    • Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
  • 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 on 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.
  • Inactive Ingredients

    Water (Aqua), Hydrated Silica, Sorbitol, Alumina, Glycerin, Tetrasodium Pyrophosphate, PEG-12, Dimethicone1, Poloxamer 3381, Poloxamer 4071, Cellulose Gum, Sodium Lauryl Sulfate, Flavor (Aroma), Sodium Saccharin, Titanium Dioxide (CI 77891).

    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 during brushing and helps reduce plaque buildup.
  • Questions

    1-888-742-7626

  • PRINCIPAL DISPLAY PANEL - 110 g Tube Label

    AP24®

    Whitening
    Fluoride
    Toothpaste

    NU SKIN®

    110 g e (4 oz.)

    PRINCIPAL DISPLAY PANEL - 110 g Tube Label
  • INGREDIENTS AND APPEARANCE
    AP-24 WHITENING 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-1155
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Sorbitol (UNII: 506T60A25R)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Pyrophosphate (UNII: O352864B8Z)  
    Polyethylene Glycol 600 (UNII: NL4J9F21N9)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Poloxamer 338 (UNII: F75JV2T505)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-1155-1110 g in 1 TUBE; 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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