Label: ALEGRIA NEO- silicon dioxide, allantoin paste, dentifrice

  • NDC Code(s): 70406-020-01, 70406-020-02
  • Packager: Seowangmo Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 3, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient: Dental Type Silica 14.0%, Aluminium Chlorohydroxy Allantoinate 0.04%

  • INACTIVE INGREDIENT

    Inactive Ingredients: D-Sorbitol Solution, Aqua, Polyethylene Glycol 1500, Mica, Concentrated Glycerin, Sodium Cocoyl Glutamate, Carboxymethylcellulose Sodium, Peppermint Oil, Anetol, Sophora Extract, Grapefruit Seed Extract, Xylitol, Glucosyl Stevia, L-Menthol, Hydroxyapatite, Eucalyptus Extract, Sage Extract, Chamomile Extract, Aloe Extract, Glycyrrhiza Extract Powder, Argentum

  • PURPOSE

    Purpose: Gum Care

  • 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 gum care

  • 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

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ALEGRIA NEO 
    silicon dioxide, allantoin paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70406-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE2.80 g  in 20 g
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.008 g  in 20 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70406-020-021 in 1 CARTON10/01/2017
    1NDC:70406-020-0120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2017
    Labeler - Seowangmo Corporation (689605288)
    Registrant - Seowangmo Corporation (689605288)
    Establishment
    NameAddressID/FEIBusiness Operations
    Seowangmo Corporation689605288manufacture(70406-020)