SALTRAIN TOOTH- sodium monofluorophosphate paste

SALTRAIN TOOTH by

Drug Labeling and Warnings

SALTRAIN TOOTH 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 Monofluorophosphate

PURPOSE

For dental care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

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

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

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

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SALTRAIN TOOTH 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74724-0021
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
AMINOCAPROIC ACID (UNII: U6F3787206)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74724-0021-1	100 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2020

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(74724-0021)