Label: GIFTEAST BAJA SALT GARGLE ORIGIN- sodium fluoride, sodium chloride mouthwash
- NDC Code(s): 83445-010-01
- Packager: FOODPORT
- Category: HUMAN OTC DRUG LABEL
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
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- Official Label (Printer Friendly)
- Active ingredient(s)
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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
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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
- Use(s)
- Directions
- Other Information
- Questions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GIFTEAST BAJA SALT GARGLE ORIGIN
sodium fluoride, sodium chloride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83445-010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.05 g in 100 mL Sodium Chloride (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) Sodium Chloride 2.0 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Xylitol (UNII: VCQ006KQ1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83445-010-01 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/01/2023 Labeler - FOODPORT (695580479) Registrant - FOODPORT (695580479) Establishment Name Address ID/FEI Business Operations DONG IL PHARMS CO., LTD. 557810721 manufacture(83445-010)
