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 0.925% (1445ppm w/v fluoride ion)

Purpose

Anti-cavity

Use

aids in the prevention of dental cavities

Warnings

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

DO NOT USE

N/A

WHEN USING

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

STOP USE

n/a

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

Directions

Adults and children 6 years of age and older; Chew tablet briefly and brush thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Do not swallow the tablet.

Supervise children under 6 years of age for brushing and rinsing.

Other Information

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

Inactive ingredients

Xylitol, Sodium Cocoyl Isethionate (made from coconut), Microcrystalline Cellulose, Calcium Carbonate, Sodium Bicarbonate, Erythritol, Natural Mint, Sodium Fluoride, Guar Gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOOTH 
toothpaste tablets tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83861-003
Route of Administration	PERIODONTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.925 mg  in 100

Inactive Ingredients
Ingredient Name	Strength
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
GUAR GUM (UNII: E89I1637KE)
CALCIUM CARBONATE (UNII: H0G9379FGK)
MINT (UNII: FV98Z8GITP)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ERYTHRITOL (UNII: RA96B954X6)

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: 83861-003-01	180 in 1 BAG; Type 0: Not a Combination Product	11/19/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/19/2024

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(83861-003)