Label: DR.NOAH SOLIDTOOTHPASTE- sodium fluoride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 29, 2021

If you are a consumer or patient please visit this version.

  • 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)