SALTRAIN TOOTH- sodium monofluorophosphate paste 
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 Monofluorophosphate

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.

Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate, D-Sorbitol Solution, Concentrated Glycerin, Polyethylene Glycol 1500, Xanthangum, Sodium Cocoyl Glutamate, Silicon Dioxide, Titanium Oxide, Enzymatically Modified Stevia, Xylitol, Sodium Chloride, Ascorbic Acid, Mentha Oil, l-Menthol, Spearmint Oil, Water

For dental use only

1

SALTRAIN TOOTH 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74724-0021
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
AMINOCAPROIC ACID (UNII: U6F3787206)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74724-0021-1100 g in 1 TUBE; Type 0: Not a Combination Product11/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/01/2020
Labeler - K.Boeun Pharmaceutical Co.,Ltd. (695674074)
Registrant - K.Boeun Pharmaceutical Co.,Ltd. (695674074)
Establishment
NameAddressID/FEIBusiness Operations
K.Boeun Pharmaceutical Co.,Ltd.695674074manufacture(74724-0021)

Revised: 11/2020
Document Id: b3cecaf6-4e27-7266-e053-2995a90a5da2
Set id: b3cec2cd-6a67-68ca-e053-2995a90ad738
Version: 1
Effective Time: 20201111
 
K.Boeun Pharmaceutical Co.,Ltd.