Label: OLOGY FLUORIDE- sodium monofluorophosphate 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 March 21, 2013

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  • Active Ingredients

    Sodium monofluorophosphate 0.76%................Anticavity (0.15% w/v fluoride ion)

  • USES

    • Helps protect against cavitites.
  • USES

    • Helps protect against cavitites.
  • Directions

    • adults and children 12 years and older: brush teeth thoroughly, preferably after each meal, or at least twice a day, or as directed by your dentist.  do not swallow.
    • children under 6 years of age: to minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.
    • children under 2 years of age: ask a dentist or physician.
  • Inactive ingredients

    glycerin, water, calcium carbonate, hydrated silica, xylitol, cellulose gum, cocamidopropyl betaine, flavour peppermint oil, sodium bicarbonate, zinc citrate, sucralose.

  • Warnings

    as with all fluoride toothpastes, keep out of reach of children under 6 years of age.  If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children under 6 years of age.

  • Principal Display Panel

    image of container

  • INGREDIENTS AND APPEARANCE
    OLOGY FLUORIDE 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2008
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    XYLITOL (UNII: VCQ006KQ1E)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Colorwhite (Fluoride) Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-2008-01133 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/21/2013
    Labeler - Walgreens (008965063)
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