Label: DR.NOAH SOLIDTOOTHPASTE- sodium fluoride tablet

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated October 29, 2021

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  • ACTIVE INGREDIENT

    Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

  • INACTIVE INGREDIENT

    D-Sorbitol,Microcrystalline Cellulose, Xylitol, Enzymatically Modified Stevia, Bamboo Salt, L-Menthol, CombinedFlavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Combined Flavor(SperamintFlavor Powder), Yuzu Extract, Chamomile Powder, Sodium Bicarbonate, Xanthan Gum,Hydroxypropylcellulose, Magnesium Stearate, Sodium Cocoyl Glutamate

  • 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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNING

    For oral use only
    When using this product

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

    Keep out of reach of children

    ■ if swallowed, seek medical help or contact the poison control center immediately

  • USES

    for oral use only

  • INDICATION & USAGE SECTION

    adults and children above the age of 6: chew tablet briefly before brushing teeth thoroughly at least twice a day, after each meal or as recommended by your doctor or dentist

    do not swallow the tablet

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DR.NOAH SOLIDTOOTHPASTE 
    sodium fluoride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82359-0003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.00154 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE0.035 g
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE0.007 g
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE0.00035 g
    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:82359-0003-1180 in 1 POUCH; Type 0: Not a Combination Product10/29/2021
    2NDC:82359-0003-230 in 1 CASE; Type 0: Not a Combination Product10/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/29/2021
    Labeler - DR.Noah (695333875)
    Registrant - DR.Noah (695333875)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUNGWON PHARMACEUTICAL CO., LTD.689787898manufacture(82359-0003)
    Establishment
    NameAddressID/FEIBusiness Operations
    DR.Noah695333875label(82359-0003)
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