Label: THE BLUE TOOTHBRUSH- sodium fluoride gel, 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 28, 2015

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  • ACTIVE INGREDIENT

    Active ingredients: Sodium Fluoride 0.22%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    D-Sorbitol solution, Doncentrated Glycerin, Sodium Lauryl Sarcosinate, Peppermint oil, L-menthol, Methylparaben, Xylitol, Ascorbic acid, Tocopherol Acetate, Brilliant Blue FCF, Water

  • PURPOSE

    Purpose: Aids in the prevention of dental decay

  • WARNINGS

    Warnings: Supervise children using the toothbrush. Coated toothpaste is initial use, 'The Blue' toothbrush is reusable with toothpaste after initial use. Please change the toothbrush every 15days or when the bristles are worn out. Store in a cool place out of humidity and direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    How to use: Use to remove the packaging and buried in a little water on the brush head.

  • DOSAGE & ADMINISTRATION

    How to use: Use to remove the packaging and buried in a little water on the brush head.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

    Image of carton

  • INGREDIENTS AND APPEARANCE
    THE BLUE TOOTHBRUSH 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69370-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0002 g  in 25 
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69370-010-0125 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/01/2014
    Labeler - New-Light Co., Ltd (687405006)
    Registrant - New-Light Co., Ltd (687405006)
    Establishment
    NameAddressID/FEIBusiness Operations
    New-Light Co., Ltd687405006manufacture(69370-010)
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