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

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.

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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

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)

Revised: 5/2023
Document Id: cc3ee472-e78e-467e-91b2-4952371bca15
Set id: b7dfa6db-79d4-4be2-a2ac-58665f2845dd
Version: 1
Effective Time: 20230517
 
FOODPORT