XEROSTOM (SODIUM FLUORIDE) PASTE [BIO COSMETICS S L]

XEROSTOM (SODIUM FLUORIDE) PASTE [BIO COSMETICS S L]
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NDC 61041-212-03
Set ID 8048f47c-8bec-411e-b00d-879efe3c806d
Category HUMAN OTC DRUG LABEL
Packager Bio Cosmetics S L
Generic Name
Product Class
Product Number
Application Number PART355
  • 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 Product02/06/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/06/2015
    Labeler - Bio Cosmetics S L (513423178)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS COSMODENT SL513012153manufacture(61041-212)

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