Label: XEROSTOM- sodium fluoride mouthwash

  • 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 August 25, 2023

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

View All Sections
  • Active Ingredient

    Sodium Fluoride 0.055%

  • Purpose Section

    Anticavity Rinse

  • Keep out of reach of children

    Keep out of reach of children 12yrs of age and under

  • Indications & Usage Section

    Aids in the prevention of dental cavities.

  • Warnings

    Keep out of reach of children 12 years of age and under.
    For external use only. If you accidentally swallow more than used for rinsing, get medical help or contact a Poisson Control Center immediately.
    Do not use if you are allergic to any of the ingredients.

  • Dosage and administration

    Adults and children over 12 years use at least twice a day after brushing.
    Pour 10 mililiters; vigorously swish 10mililiters of rinse between teeth for I minute.
    Then spit out.

  • Inactive Ingredient

    Water
    Betaine
    Glycerin
    Peg-40 Hydrogenated Castor Oil
    Propylene Glycol
    Xylitol
    Aroma
    Potassium Phosphate
    Diazolidinyl Urea
    Allantoin
    Olive oil
    Sodium Methyl paraben
    Sodium Propyl Paraben
    Chlorophyll
    D-Panthenol
    Tocopheryl Acetate
    Sucralose
    Parsley Oil.

  • Principal Display panel

    image description

  • INGREDIENTS AND APPEARANCE
    XEROSTOM 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61041-211
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.559 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BETAINE (UNII: 3SCV180C9W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ALLANTOIN (UNII: 344S277G0Z)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    CHLOROPHYLL (UNII: 00WNZ48OR9)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PARSLEY OIL (UNII: IXK9N7RJ7J)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61041-211-091 in 1 CARTON11/15/201310/31/2024
    1250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/15/201310/31/2024
    Labeler - Bio Cosmetics (513423178)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS COSMODENT SL513012153manufacture(61041-211)
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!