TOOTH- toothpaste tablets tablet

Tooth by

Drug Labeling and Warnings

Tooth by is a Otc medication manufactured, distributed, or labeled by Henan Dailygreen Biotechnology Co. LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium Fluoride 1.54mg (0.7mg fluoride ion)

Purpose

Anti-cavity

Use

Aids in the prevention of dental cavities

Warnings

- Use this product only for brushing your teeth.

- Do not swallow the toothpaste tablets.

- Keep out of reach of children.

- Small tablets may be a choking hazard for children under 3 years old.

- Keep toothpaste away from pets.

- If you experience any irritation or sensitivity while using this product, discontinue use.

DO NOT USE

N/A

WHEN USING

n/a

STOP USE

If you experience any irritation or sensitivity while using this product, discontinue use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

- 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.

Other Information

Store at 1-30 °℃ (33.8 - 86°F).

Protect from excessive moisture.

Inactive ingredients

Silica, Tetrasodium pyrophosphate, Pyridoxine HCI (Vitamin B6), Sorbitol, Microcrystalline cellulose, Xylitol, Stevia rebaudiana extract, Sodium chloride, Hydroxypropyi cellulose, Xanthan gum, Sodium cocoyl glutamate, Sodium bicarbonate, Magnesium stearate, Hydroxyapatite, Tocopheryl acetate (Vitamin E), Sodium ascorbate (Vitamin C), Menthol, Flavor, Camellia sinensis leaf extract, Eucalyptus globulus leaf oil, Rosmarinus officinalis (Rosemary) leaf extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOOTH 
toothpaste tablets tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83861-002
Route of Administration	PERIODONTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.54 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
PYRIDOXINE (UNII: KV2JZ1BI6Z)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
MAGNESIUM STEARATE (UNII: 70097M6I30)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ROSEMARY (UNII: IJ67X351P9)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM ASCORBATE (UNII: S033EH8359)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MENTHOL (UNII: L7T10EIP3A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	11mm
Flavor	MINT (Mint, citrus, cinnamon mixed flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83861-002-01	43.4 g in 1 BOX; Type 0: Not a Combination Product	09/27/2024
2	NDC: 83861-002-02	43.4 g in 1 BOX; Type 0: Not a Combination Product	09/27/2024
3	NDC: 83861-002-03	173.6 g in 1 BOX; Type 0: Not a Combination Product	09/27/2024
4	NDC: 83861-002-04	173.6 g in 1 BOX; Type 0: Not a Combination Product	09/27/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/27/2024

Labeler - Henan Dailygreen Biotechnology Co. LTD (699305250)

Registrant - Henan Dailygreen Biotechnology Co. LTD (699305250)

Establishment
Name	Address	ID/FEI	Business Operations
Henan Dailygreen Biotechnology Co. LTD		699305250	manufacture(83861-002)