Label: DELIXIR G TOOTHPASTE- sodium fluoride paste, dentifrice

  • NDC Code(s): 83466-010-01, 83466-010-02
  • Packager: Froncare, Inc.
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated May 17, 2023

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  • Active ingredient

    Sodium Fluoride 0.11%

  • Inactive ingredients

    Sorbitol, Water, Hydrated Silica, Glycerin, Hydroxyapatite, Tetrasodium Pyrophosphate, Xylitol, Cellulose Gum, Sodium Cocoyl Glutamate, Rubus Idaeus Fruit Extract, Sodium Methyl Cocoyl Taurate, Floral Flavor, Stevioside, Tocopheryl Acetate, Centella Asiatica Extract, Sodium Chloride, Floral Mint Flavor, Chamomilla Recutita Flower Extract, Salvia Officinalis Leaf Extract, Eucalyptus Globulus Leaf Extract, Lactuca Scariola Sativa Leaf Extract, Bioactive Herb Complex-C, Myrrha Essence, Menthol, Malt Extract

  • Purpose

    Anti cavity

  • Warnings

    ■ Rinse the mouth thoroughly after use.
    ■ Keep out of the reach of children under 6 years of age.
    ■ If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

  • KEEP OUT OF REACH OF CHILDREN

    ■ Keep out of the reach of children under 6 years of age.

  • Use(s)

    ■ Aids in the prevention of dental cavities.
    ■ Keeps your teeth strong.
    ■ Keeps your mouth clean.
    ■ Refreshes the inside of the mouth.
    ■ Removes bad breath.
    ■ Increases aesthetic effect.
    ■ Prevents periodontal disease.
    ■ Removal of plaque(anti-plaque)

  • Directions

    ■ Apply a pea-sized amount of toothpaste on the brush. Brush teeth thoroughly after each meal or at least twice a day.

  • Other Information

    ■ Store below 30℃ (86℉)

  • Questions

    ■ 1-929-800-1016

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DELIXIR G TOOTHPASTE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83466-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83466-010-021 in 1 CARTON05/01/2023
    1NDC:83466-010-01120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2023
    Labeler - Froncare, Inc. (040424783)
    Registrant - Froncare, Inc. (040424783)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(83466-010)
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