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

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  • Active Ingredient

    Sodium Fluoride 0.055%

  • Purpose

    Anticavity Rinse

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Indications and Uses aids in the prevention of dental cavities

  • Warnings

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

  • Directions

    Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients 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.

  • STORAGE AND HANDLING

    Other information store below 25°C (77°F)

  • QUESTIONS

    Questions? info@biocosmetics.es

    USA/Canada Toll Free: 1-855-688-5385 weekdays from 6.00 a.m. to 2.00 p.m.

  • Packaging

    mouthwashlbl

  • 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:61041-211-3115 mL in 1 PACKET; Type 0: Not a Combination Product02/06/201510/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/06/201510/31/2024
    Labeler - Bio Cosmetics (513423178)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS COSMODENT SL513012153manufacture(61041-211)
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