Label: GIFTEAST BAJA SALT TOOTHPASTE ORIGIN- sodium chloride, hydrated silica, sodium fluoride, tocopheryl acetate paste, dentifrice

  • NDC Code(s): 83445-020-01, 83445-020-02
  • Packager: FOODPORT
  • 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 May 17, 2023

If you are a consumer or patient please visit this version.

  • Active ingredient(s)

    Sodium Chloride 5%
    Hydrated Silica 13%
    Sodium Fluoride 0.22%
    Tocopheryl Acetate 0.2%

  • Inactive ingredients

    Sorbitol, Water, Glycerin, Xylitol, Sodium Methyl Cocoyl Taurate, Cellulose Gum, Sodium Cocoyl Glutamate, Menthol, Rubus Idaeus Fruit Extract, Herb Mint Flavor, Mentha Piperita Oil, Mint Flavor, Stevioside, Cooling Flavor, Sodium Bicarbonate, Aloe Barbadensis Leaf Extract, Salvia Officinalis Leaf Extract, Chamomilla Recutita Flower Extract, Eucalyptus Globulus Leaf Extract, Olea Europaea Leaf Extract

  • Purpose

    Anticavity, acc
    Antiplague
    Anticavity
    Anticavity, Antigingivitis, acc

  • Warnings

    ■ Be careful not to swallow, and rinse your mouth thoroughly after use.
    ■ If this toothpaste causes abnormalities such as gum or mouth damage, please stop using it and consult your doctor or dentist.
    ■ Keep out of reach of children under the age of 6, and if a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately.

  • KEEP OUT OF REACH OF CHILDREN

    ■ Keep out of reach of children under the age of 6, and if a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately.

  • Use(s)

    ■ aids in the prevention of cavities.
    ■ helps to remove bad breath.
    ■ helps Keep teeth white and strong.
    ■ helps prevent gingivitis and periodontitis.
    ■ helps to remove plaque (antiplague).

  • Directions

    ■ adults and children 7 years of age and older : brush your teeth thoroughly, preferably after each meal or at least twice a day. It is appropriate to use an amount of about 1 cm.
    ■ children 2 to 7 years : use about 5mm and supervise child's brushing and rinsing

  • Other Information

    ■ Store below 30℃(86℉), Do not store this product in an inappropriate place, such as at high or low temperatures, under direct sunlight

  • Questions

    www.gifteast.org

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    GIFTEAST BAJA SALT TOOTHPASTE ORIGIN 
    sodium chloride, hydrated silica, sodium fluoride, tocopheryl acetate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83445-020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Chloride (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) Sodium Chloride5.0 g  in 100 g
    HYDRATED SILICA (UNII: Y6O7T4G8P9) (HYDRATED SILICA - UNII:Y6O7T4G8P9) HYDRATED SILICA13.0 g  in 100 g
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Xylitol (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83445-020-021 in 1 CARTON05/01/2023
    1NDC:83445-020-0180 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 - FOODPORT (695580479)
    Registrant - FOODPORT (695580479)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(83445-020)