GIFTEAST BAJA SALT GARGLE ORIGIN- sodium fluoride, sodium chloride mouthwash 
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 Fluoride 0.05%
Sodium Chloride 2.0%

Inactive ingredients

Water, Glycerin, Xylitol, PEG-40 Hydrogenated Castor Oil, Rubus Idaeus Fruit Extract, Fruit Mix Flavor, Sodium Benzoate, Polysorbate 20, Stevioside, Citric Acid, Grapefruit Flavor, Salvia Officinalis Leaf Extract, Eucalyptus Globulus Leaf Extract, Chamomilla Recutita Flower Extract, Aloe Barbadensis Leaf Extract, Mentha Piperita Oil, Citrus Limon Fruit Oil, Sodium Citrate, Menthol, Salicylic Acid, Glycyrrhiza Uralensis Root Extract

Purpose

Anticavity
Anticavity, acc

WARNINGS

■ Be careful not to swallow, and rinse your mouth thoroughly after use.
■ If this product 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 prevent and reduce plaque (antiplague).
■ helps to remove bad breath.

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 10ml
■ children 2 to 7 years : use about 6ml and supervise child's brushing and rinsing

Other Information

■ Store below 30℃(86℉)

Questions

www.gifteast.org

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

GIFTEAST BAJA SALT GARGLE ORIGIN 
sodium fluoride, sodium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83445-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
Sodium Chloride (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) Sodium Chloride2.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Xylitol (UNII: VCQ006KQ1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83445-010-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2023
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(83445-010)

Revised: 5/2023
Document Id: 62463456-a6c9-4c83-8bbf-d2c7f1aaa944
Set id: 9d901371-3586-48f1-ab30-e99b0d196e21
Version: 1
Effective Time: 20230517
 
FOODPORT