TIDALOVE SMILE MORE ORAL CARE- sodium fluoride tablet tablet

TIDALOVE SMILE MORE ORAL CARE by

Drug Labeling and Warnings

TIDALOVE SMILE MORE ORAL CARE by is a Otc medication manufactured, distributed, or labeled by Paranmare, SUNGWON PHARMACEUTICAL CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TIDALOVE SMILE MORE ORAL CARE 
sodium fluoride tablet tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82756-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.7 mg  in 1.54 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor	CITRUS	Imprint Code	none
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82756-001-11	1.54 mg in 1 BAG; Type 0: Not a Combination Product	06/10/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/01/2022

TIDALOVE SMILE MORE ORAL CARE 
sodium fluoride tablet tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82756-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.7 mg  in 1.54 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor	CINNAMON	Imprint Code	none
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82756-002-11	1.54 mg in 1 BAG; Type 0: Not a Combination Product	06/10/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/01/2022

Labeler - Paranmare (049281321)

Establishment
Name	Address	ID/FEI	Business Operations
SUNGWON PHARMACEUTICAL CO., LTD		689787898	manufacture(82756-001, 82756-002)