SALTRAIN TOOTH by DONG IL PHARMS CO., LTD.

SALTRAIN TOOTH by

Drug Labeling and Warnings

SALTRAIN TOOTH 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 TOOTH- sodium fluoride paste 
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

Apply an appropriate amount to your toothbrush and brush your teeth by brushing

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, Sage Extract, Aloe Extract, Eucalyptus Extract, Water

For dental use only

1

SALTRAIN TOOTH 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73242-0021
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73242-0021-1100 g in 1 TUBE; Type 0: Not a Combination Product10/01/202011/03/2020
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(73242-0021)

Revised: 11/2020
Document Id: b32e1dc8-eca6-bd63-e053-2995a90afcf0
Set id: b2c70e4d-3b33-4fc6-e053-2a95a90a1175
Version: 2
Effective Time: 20201103