Label: XEROSTOM- sodium fluoride paste

  • 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 0.22%

  • Purpose Section

    Anticavity 

  • 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 brushing, 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 apply toothpaste onto a soft bristle toothbrush brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
    Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good
    habits are established.

  • Inactive Ingredient

    Glycerin
    Water
    Hydrated Silica
    Xylitol
    Betaine
    Tetrapotassium Pyrophosphate
    Olive Oil
    Xanthan Gum
    Titanium Dioxide
    Potassium Phosphate
    Flavor
    Diazolidinyl Urea
    Papain, Parsley Oil
    D-Panthenol
    Tocopheryl Acetate.

  • Principal Display panel

    image description

  • INGREDIENTS AND APPEARANCE
    XEROSTOM 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61041-212
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    BETAINE (UNII: 3SCV180C9W)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PAPAIN (UNII: A236A06Y32)  
    PARSLEY OIL (UNII: IXK9N7RJ7J)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61041-212-011 in 1 CARTON11/08/201304/30/2025
    164 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/08/201304/30/2025
    Labeler - Bio Cosmetics S L (513423178)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS COSMODENT SL513012153manufacture(61041-212)
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