SALTRAIN CLEAN BREATH by DONG IL PHARMS CO., LTD.

SALTRAIN CLEAN BREATH by

Drug Labeling and Warnings

SALTRAIN CLEAN BREATH by is a Otc medication manufactured, distributed, or labeled by DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SALTRAIN CLEAN BREATH- sodium fluoride mouthwash 
DONG IL PHARMS 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

1

SALTRAIN CLEAN BREATH 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73242-0022
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73242-0022-115 in 1 BOX10/01/202011/03/2020
112 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/01/202011/03/2020
Labeler - DONG IL PHARMS CO., LTD. (557810721)
Registrant - DONG IL PHARMS CO., LTD. (557810721)
Establishment
NameAddressID/FEIBusiness Operations
DONG IL PHARMS CO., LTD.557810721manufacture(73242-0022)

Revised: 11/2020
Document Id: b32bac56-41ea-9cfa-e053-2a95a90a0497
Set id: b2c94a81-0011-6601-e053-2a95a90ae46f
Version: 2
Effective Time: 20201102