Label: TIDALOVE SMILE MORE ORAL CARE- sodium fluoride tablet 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 December 8, 2022

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  • Active Ingredients(in each tablet) purpose

    Sodium fluoride 1.54mg (0.7mg fluoride ion) anticavity

  • Inactive Ingredients

    silicon dioxide, tetrasodium pyrophosphate, pyridoxine hydrochloride(vitamin B6), D-sorbitol, microcrystalline cellulose, xylitol, enzymatically modified stevia, bamboo salt, hydroxypropylcellulose, xanthan gum, sodium cocoyl glutamate, sodium bicarbonate, magnesium stearate, hydroxyapatite, tocopherol acetate(vitamin E), sodium ascorbate (vitamin C), L-menthol, combined flavor, green tea extract, eucalyptus oil, rosemary extract

  • PURPOSE

    Aids in the prevention of dental cavities

  • WHEN USING

    ▪ Adults and children 6 years of age and older: Chew 1 tablet until crushed.
    ▪ Brush teeth thoroughly at least twice a day, or use as directed by a dentist or physician.

    ▪ Spit out: Do not swallow the tablet.
    ▪ Children under 6 years of age should be supervised when using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • ASK DOCTOR

    Brush teeth thoroughly at least twice a day, or use as directed by a dentist or physician.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • WARNINGS

    Do not use it for anything other than brushing teeth, and be careful not to swallow it.
    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.Keep out of the reach of children.

    Small tablets may be a chocking hazard for children under 3 years old.
    Keep it away from the pets.
    When using this product, if irritation or sensitivity occurs, discontinue use.

  • DO NOT USE

    When using this product, if irritation or sensitivity occurs, discontinue use.

  • OTHER SAFETY INFORMATION

    Store at 25-30 °C (68-77°F). Protect from excessive moisture.

  • DOSAGE & ADMINISTRATION

    Gently chew 1 tablet until it crushed. Brush teeth thoroughly,

  • INDICATIONS & USAGE

    Adults and children 6 years of age and older: Chew 1 tablet until crushed.
    Brush teeth thoroughly at least twice a day, or use as directed by a dentist or physician.

    Spit out: Do not swallow the tablet.
    Children under 6 years of age should be supervised when using this product.

  • PRINCIPAL DISPLAY PANEL

    drug factsdrug facts

  • INGREDIENTS AND APPEARANCE
    TIDALOVE SMILE MORE ORAL CARE 
    sodium fluoride tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82756-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.7 mg  in 1.54 mg
    Inactive Ingredients
    Ingredient NameStrength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SORBITOL (UNII: 506T60A25R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ROSEMARY (UNII: IJ67X351P9)  
    SEA SALT (UNII: 87GE52P74G)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorCITRUSImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82756-001-111.54 mg in 1 BAG; Type 0: Not a Combination Product06/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2022
    TIDALOVE SMILE MORE ORAL CARE 
    sodium fluoride tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82756-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.7 mg  in 1.54 mg
    Inactive Ingredients
    Ingredient NameStrength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    XYLITOL (UNII: VCQ006KQ1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    SORBITOL (UNII: 506T60A25R)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SEA SALT (UNII: 87GE52P74G)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorCINNAMONImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82756-002-111.54 mg in 1 BAG; Type 0: Not a Combination Product06/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2022
    Labeler - Paranmare (049281321)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUNGWON PHARMACEUTICAL CO., LTD689787898manufacture(82756-001, 82756-002)
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