Label: MAXIXUM SECURITY GEL TOOTHPASTE- fluoride toothpaste 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 August 25, 2008

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  • SPL UNCLASSIFIED SECTION

    NET WT 0.15 OZ

  • DRUG FACTS:

  • ACTIVE INGREDIENT

    Sodium fluoride- 0.22% (0.1% w/v fluoride ion)

  • PURPOSE

    Anticavity.

  • USE

    Helps protect against cavities.

  • WARNINGS

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • DIRECTIONS:

    Adults & Children 6 years of age & older:

    Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

    Children 2 to 6 years:

    Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).

    Children under 2 years:

    Ask a dentist or physician.

  • INACTIVE INGREDIENTS

    Purified Water, Sorbitol, Carbopol, Sodium Lauryl Sulphate, Flavor, Poly Ethylene Glycol 1500, Sodium Saccharin, Precipitated Silica, Sodium Carboxy Methyl Cellulose, Methyl Paraben, Propyl Paraben.

    Product of India,
    Exclusive Distributor:
    Bob Barker Co. Inc.,
    Phone: 1-800-334-9880.
    Expires: 3 years from the Date of Mfg.

    C.No. DNH/COS/DNH/52
    Mfg. Date & Batch No. on crimp.

    24.06.2009

    MAXIMUM SECURITY GEL TOOTHPASTE
    ACTIVE INGREDIENT: SODIUM FLUORIDE - 0.22 %
    (0.1% w/v fluoride Ion)
    SR. NO. INGREDIENTS

    1. Treated water
    2. Sorbitol
    3. Carbopol
    4. Sodium lauryl sulphate
    5. Flavor
    6. Polyethylene glycol 1500
    7. Sodium saccharin
    8. Precipitated Silica
    9. Sodium Carboxy Methyl Cellulose
    10. Methyl Paraben
    11. Propyl Paraben
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    Packet Label
    TEAR HERE
    MAXIMUM SECURITY®
    GEL TOOTHPASTE
    NET WT 0.15 OZ

    Packet Label
  • INGREDIENTS AND APPEARANCE
    MAXIXUM SECURITY GEL TOOTHPASTE 
    fluoride toothpaste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68747-6028
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68747-6028-14.2 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/25/2009
    Labeler - Dabur India Limited (650319218)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dabur India Limited650319218MANUFACTURE
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