Label: SALTRAIN CLEAN BREATH- sodium fluoride mouthwash

  • NDC Code(s): 74724-0020-1
  • Packager: K.Boeun Pharmaceutical Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 10, 2020

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  • ACTIVE INGREDIENT

    Sodium Flouride

  • PURPOSE

    For dental care

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Put an appropriate amount in your mouth, gargle for 30 seconds, spit out, and brush your teeth by brushing

    Do not swallow

  • 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

    Concentrated Glycerin, Polyethylene Glycol 1500, Polysorbate 20, Xylitol, Sodium Chloride, I-Menthol, Mentha Oil, Sage Extract, Aloe Extract, Eucalyptus Extract, Water

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    SALTRAIN CLEAN BREATH 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74724-0020
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74724-0020-115 in 1 BOX11/01/2020
    112 mL in 1 POUCH; Type 0: Not a Combination Product
    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(74724-0020)
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