Label: LAURA LYNN ANTICAVITY- 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 November 30, 2010

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  • Active Ingredient

    SODIUM FLUORIDE 0.243% (0.15% WITH FLUORIDE ION)...ANTICAVITY TOOTHPASTE

  • PURPOSE


  • KEEP OUT OF REACH OF CHILDREN


  • USE

    Helps protect against cavities

  • 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.

  • Directions

    Adults and children        Brush teeth thoroughly, preferably after
    2 years and older         each meal, or at least twice a day, or as
                                             directed by your dentist. Do not swallow.

    Children under                 To minimize swallowing, use a pea-
    6 years and older            sized amount and supervise brushing
                                             until good habits are established.

    Children under 2 years   Ask a dentist or physician.


  • Inactive ingredients:

    Calcium Carbonate, Soribitol, Water, Hydrated Silica, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Sodium Phosphate, Sodium Benzoate, Titanium Dioxide, Tetrasodium Pyrophosphate, Sodium Saccharin, Triclosan

  • Principal Display Panel



    image of container



  • INGREDIENTS AND APPEARANCE
    LAURA LYNN ANTICAVITY  
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67659-041
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Refreshing Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67659-041-05181.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/29/2006
    Labeler - Team Technologies, Inc (192339703)
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