UPC 801803 00211 MEGAFRESH GEL FLUORIDE TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]

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UPC 801803 00211 MEGAFRESH GEL FLUORIDE TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]
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NDC 54157-109-01, 54157-109-02, 54157-109-03, 54157-109-04, 54157-109-05, 54157-109-06, 54157-109-07, 54157-109-08, 54157-109-09
Set ID 42824602-9b12-449d-9888-ade5a97ce129
Category HUMAN OTC DRUG LABEL
Packager American Amenities, Inc.
Generic Name
Product Class
Product Number
Application Number PART355
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  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Fluoride (0.243%)

  • 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

    Sorbitol, Hydrated Silica, Glycerin, Purified Water, Polyethylene Glycol, Sodium Lauryl Sulfate,  Carboxymethylcellulose Sodium, Flavor, Xanthan Gum, Saccharin Sodium, Methylisothiazolinone

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    UPC 801803 00211 MEGAFRESH GEL FLUORIDE TOOTH 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54157-109
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54157-109-0117 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    2NDC:54157-109-0224 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    3NDC:54157-109-0343 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    4NDC:54157-109-0478 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    5NDC:54157-109-0585 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    6NDC:54157-109-06130 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    7NDC:54157-109-07181 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    8NDC:54157-109-08200 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
    9NDC:54157-109-094.25 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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