Label: T-SERIES- sodium fluoride tablet

  • 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 October 18, 2019

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  • ACTIVE INGREDIENT

    sodium fluoride

  • INACTIVE INGREDIENT

    silica, sodium pyrophosphate, pyridoxine hydrochloride, D-sorbitol, microcrystalline cellulose, xylitol, sodium bicarbonate, tea extract, tocopherol acetate, etc

  • PURPOSE

    ■ Keeps teeth white and strong

    ■ Keep the oral cavity clean

    ■ Prevents tooth decay and bad breath caused by fluoride

    ■ Removing plaque, preventing gingivitis and periodontitis

    ■ Periodontal Disease Prevention

    ■ Gum Disease Prevention

    ■ Prevention of tartar deposition

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNING

    For oral use only
    When using this product

    ■ This toothpaste has a 1,000 ppm fluoride content

    ■ Do not use other than brushing teeth and be careful not to swallow

    Keep out of reach of children

    ■ if swallowed, get medical help or contact a person control center immediately

  • USES

    for oral use only

  • INDICATION & USAGE SECTION

    ■ Within 3 times a day, chew 1 or 2 tablets sufficiently and then brush your teeth by brushing or brush your teeth by brushing them

    ■ scrub softly as like doing massage

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    T-SERIES 
    sodium fluoride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76058-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76058-001-0160 in 1 BOTTLE; Type 0: Not a Combination Product10/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/19/2019
    Labeler - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)
    Registrant - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUNGWON PHARMACEUTICAL CO., LTD.689787898manufacture(76058-001)
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