Label: LAURA LYNN ANTICAVITY WHITENING PLUS MOUTHWASH- 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 January 24, 2011

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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 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 of age                 sized amount and supervise brushing
                                             until good habits are established.

    Children under 2 years  Ask a dentist or physician.

  • Inactive Ingredients:

    Sorbitol,Water,Hydrated Silica,PEG-6,Sodium Lauryl Sulphate,Alcohol (1.14%),Flavor,Xanthan Gum,Sodium Benzoate,Titanium Dioxide,Tetrasodium Pyrophosphate,Sodium Saccharin,Triosan,Blue 1,Yellow 4

  • PRINCIPAL DISPLAY PANEL

    image of container

  • INGREDIENTS AND APPEARANCE
    LAURA LYNN ANTICAVITY WHITENING PLUS MOUTHWASH 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62936-0042
    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)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALCOHOL (UNII: 3K9958V90M) 1.14 mg  in 1 g
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER 934 (UNII: Z135WT9208)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINT (Minty Fresh) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62936-0042-5181.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/29/2003
    Labeler - Ingles Market Inc (024418584)
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