SALTRAIN CLEAN BREATH- sodium fluoride mouthwash
K.Boeun Pharmaceutical Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sodium Flouride

For dental care

Keep out of reach of children

Put an appropriate amount in your mouth, gargle for 30 seconds, spit out, and brush your teeth by brushing

Do not swallow

Keep out of reach of children under 6 years old.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Concentrated Glycerin, Polyethylene Glycol 1500, Polysorbate 20, Xylitol, Sodium Chloride, I-Menthol, Mentha Oil, Sage Extract, Aloe Extract, Eucalyptus Extract, Water

For dental use only

SALTRAIN CLEAN BREATH
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74724-0020
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.02 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74724-0020-1	15 in 1 BOX	11/01/2020
1		12 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	11/01/2020

Labeler - K.Boeun Pharmaceutical Co.,Ltd. (695674074)

Registrant - K.Boeun Pharmaceutical Co.,Ltd. (695674074)

Name	Address	ID/FEI	Business Operations
Establishment
K.Boeun Pharmaceutical Co.,Ltd.		695674074	manufacture(74724-0020)