Label: ORAL DEFENSE- sodium fluoride paste, dentifrice

  • 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 5, 2013

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  • Drug Facts

  • Purpose

    Anti-Cavity toothpaste

  • Active Ingredient

    Sodium Fluoride 0.25% (0.14 w/v Fluoride Ion)

  • Use

    Aids in prevention of dental cavities and gingivitis.

  • Warnings

    Children under two years of age: Consult a dentist or physician. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Keep out of the reach of children under 6 years of age.

  • 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.

    For maximum benefits, brush for 1 minute at bedtime and use with Oral Defense Fluoride Rinse.

  • Question and Comments?

    1-800-355-9621 • 1-509-326-6693 Office

    Manufactured for: Oral Defense LLC, P.O. Box 8267 Spokane, WA 99203

    Patent No. US 6,861,047B

  • Inactive Ingredients

    Sorbitol, Purified Water, Glycerin, Hydrated Silica, Sodium Lauroyl Sarconsinate, Cellulose Gum, Flavor, Titanium Dioxide, Cetylpyridinium Chloride, Citric Acid, Sodium Saccharin, FD&C Blue No. 1, Dehydroacetic Acid.

  • PRINCIPAL DISPLAY PANEL

    image descriptiontube

  • INGREDIENTS AND APPEARANCE
    ORAL DEFENSE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52644-003
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.14 g  in 118 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    water (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CETYLPYRIDINIUM (UNII: CUB7JI0JV3)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    Product Characteristics
    Colorblue (blue (FD and C Blue No. 1)) Score    
    ShapeSize
    FlavorMINT (MINT (Fluoride Toothpaste Flavor Mint)) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52644-003-011 in 1 BOX
    1NDC:52644-003-00118 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/12/2011
    Labeler - Oral Defense (962643164)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coastal Products Company782445688manufacture(52644-003)
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