Label: UPC 801803 00203 MEGAFRESH FLUORIDE TOOTH- sodium monofluorophosphate paste, dentifrice

  • 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 June 3, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Monofluorophosphate (0.76%)

  • PURPOSE

    Purpose: Anticavity

  • INDICATIONS & USAGE

    Uses: Aids in the prevention of dental cavities

  • WARNINGS

    If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under six years of age

  • DOSAGE & ADMINISTRATION

    Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or doctor.

  • INACTIVE INGREDIENT

    Calcium Carbonate, Purified Water, Sorbitol, Polyethylene Glycol, Sodium Lauryl Sulfate, Hydrated Silica, Carboxymethylcellulose Sodium, Flavor, Guar Gum, Saccharin Sodium, Methylisothiazolinone

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    UPC 801803 00203 MEGAFRESH FLUORIDE TOOTH 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54157-108
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    GUAR GUM (UNII: E89I1637KE)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54157-108-0117 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    2NDC:54157-108-0224 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    3NDC:54157-108-0343 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    4NDC:54157-108-0478 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    5NDC:54157-108-0585 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    6NDC:54157-108-06130 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    7NDC:54157-108-07181 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    8NDC:54157-108-08200 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    9NDC:54157-108-094.25 g in 1 POUCH; Type 0: Not a Combination Product06/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/03/2017
    Labeler - American Amenities, Inc. (181454026)
    Registrant - American Amenities, Inc. (181454026)
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