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

  • NDC Code(s): 74724-0031-1
  • Packager: K.Boeun Pharmaceutical Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 31, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    label

  • INGREDIENTS AND APPEARANCE
    SALTRAIN LTOOTHPASTE 
    sodium chloride, precipitated calcium carbonate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74724-0031
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE3 g  in 100 g
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE33 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74724-0031-1180 g in 1 TUBE; Type 0: Not a Combination Product01/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2023
    Labeler - K.Boeun Pharmaceutical Co.,Ltd. (695674074)
    Registrant - K.Boeun Pharmaceutical Co.,Ltd. (695674074)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.Boeun Pharmaceutical Co.,Ltd.695674074manufacture(74724-0031)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!