TIDALOVE SMILE MORE ORAL CARE- sodium fluoride tablet tablet 
Paranmare

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.

----------

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

Aids in the prevention of dental cavities

▪ 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 the reach of children.

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.

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.

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

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

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

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.

drug factsdrug facts

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)

Revised: 12/2022
Document Id: ef56a2cf-43c0-5984-e053-2995a90a2980
Set id: e105f45c-2dc6-9ff3-e053-2a95a90a118d
Version: 4
Effective Time: 20221208
 
Paranmare