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

    Anticavity 

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Indications & Uses aids in the prevention of dental cavities

  • Warnings

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

  • Directions

    Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 year of age: Consult a dentist or doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients 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.

  • QUESTIONS

    Questions? info@biocosmetics.es

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

  • STORAGE AND HANDLING

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

  • Packaging

    toothpastelbl

  • 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:61041-212-036.5 g in 1 PACKET; Type 0: Not a Combination Product02/06/201504/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/06/201504/30/2025
    Labeler - Bio Cosmetics S L (513423178)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS COSMODENT SL513012153manufacture(61041-212)
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