SALTRAIN CLEAN BREATH- sodium fluoride mouthwash

SALTRAIN CLEAN BREATH by

Drug Labeling and Warnings

SALTRAIN CLEAN BREATH by is a Otc medication manufactured, distributed, or labeled by K.Boeun Pharmaceutical Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Flouride

PURPOSE

For dental care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

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

Do not swallow

WARNINGS

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.

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SALTRAIN CLEAN BREATH 
sodium fluoride mouthwash

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/01/2020

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

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

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