Label: ALEGRIA- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 February 25, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Monofluorophosphate 0.76%

  • INACTIVE INGREDIENT

    Inactive Ingredients: D-Sorbitol Solution, Silicon Dioxide, Dentaltype silica, Polyethylene Glycol 1500, Glycerin, Sodium Lauryl Sulfate, Carboxymethylcellulose Sodium, Sodium Benzoate, Allantonie Chlorohydroxy Aluminum, Aminocaproic Acid, Xylitol, Saccharin Sodium Hydrate, Licorice Extract, Sophora Extract, Aloevera Gel, Peppermint Oil, L-Menthol, Anethole, Carvone, Mica, Silver foil, Purified Water

  • PURPOSE

    Purpose: Anticavity

  • WARNINGS

    Warnings: If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: Keep out of reach of children under 6 years of age.

  • Use

    Use: Aids in the prevention of dental cavities

  • Directions

    Directions: 1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. 2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. 3) Children under 2 years: Consult a dentist or doctor.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ALEGRIA 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70406-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.98 g  in 130 g
    Inactive Ingredients
    Ingredient NameStrength
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70406-010-01130 g in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/02/2016
    Labeler - Seowangmo corporation (689605288)
    Registrant - Seowangmo corporation (689605288)
    Establishment
    NameAddressID/FEIBusiness Operations
    Seowangmo corporation689605288manufacture(70406-010)
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