SALTRAIN LTOOTHPASTE- sodium chloride, precipitated calcium carbonate paste, dentifrice

SALTRAIN LTOOTHPASTE by

Drug Labeling and Warnings

SALTRAIN LTOOTHPASTE 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 Chloride, Precipitated Calcium Carbonate

INACTIVE INGREDIENT

D-Sorbitol Solution
Concentrated Glycerin
Polyethylene Glycol 1500
Xanthan gum
Titanium Oxide
Silicon Dioxide
Sodium Cocoyl Glutamate
Enzymatically Modified Stevia
Xylitol
Ascorbic Acid
Tocopherol Acetate
Propolis Extract
Green Tea Extract

Aloe Extract
l-Menthol
Mentha Oil
Lemon Oil
Water

PURPOSE

aids in the prevention of dental cavities

plaque removal (anti-plaque)

prevention of periodontal disease, prevention of gum disease

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

Warnings

Keep out of reach of children

■ If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Other Information

■ Store in an airtight container at room temperature

■ Date of use : 36 months from the date of manufacture

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SALTRAIN LTOOTHPASTE 
sodium chloride, precipitated calcium carbonate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74724-0031
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	3 g  in 100 g
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	33 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74724-0031-1	180 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2023

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(74724-0031)