Label: DOCTORTIBLETKEREALE- 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 29, 2018

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  • ACTIVE INGREDIENT

    Active ingredients: Sodium Fluoride 0.22%

  • INACTIVE INGREDIENT

    Inactive ingredients: D-Sorbitol, Sodium Lauryl Sulfate, Silicon Dioxide, Xylitol, microcrystalline cellulose, Mint Flavor, Magnesium Sterate, L-Menthol, Hydroxypropylellulose, Tetrasodium Pyrophosphate, sodium hydrogen carbonate, aspartame, Arabic Gum, Pyridoxine HCI, Ascorbic Acid

  • PURPOSE

    Purpose: Anticaries

  • WARNINGS

    Warnings: Keep out of the reach of children under 6 years of age. Do not use children because they may swallow. If large quantities have been swallowed, consult a physician immediately.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    Uses: Help better oral hygiene and freshness breath.

  • Directions

    Directions: Take one of Kereale mouth rinse tablet chewing until it melting completely in your mouth and mix with some water then spit it out.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DOCTORTIBLETKEREALE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72047-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.001 g  in 0.7 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72047-010-0260 in 1 CARTON01/02/2018
    1NDC:72047-010-010.7 g in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/02/2018
    Labeler - TRAUM TRADERS (694894613)
    Registrant - TRAUM TRADERS (694894613)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sungwon Pharmaceutical Co., Ltd689787898manufacture(72047-010)
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