Tooth by Henan Dailygreen Biotechnology Co. LTD 83861-004

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]

TOOTH- toothpaste tablets tablet 
Henan Dailygreen Biotechnology Co. LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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83861-004

Active ingredient

Sodium monofluorophosphate 1,1%(1450ppm)

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 tabiets. Keep out of reach of children under 6 years of age and out of reach of pets. If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

Do not swallow the toothpaste tabiets.

n/a

n/a

Keep out of reach of children under 6 years of age and out of reach of pets.

Directions

Crush the tab between your teeth. Brush like normal for 2 minutes and spit out.Brush preferably after each meal, or at least twice a day, or as directed by your dentist. DO NOT SWALLOW.Children under the age of6 - DO NOT USE

Other Information

Store the toothpaste tabs in our refill pack in a cool and dry place or airtight in our glass storage bottle or in another airtight bottle or box.

Inactive ingredients

Sorbitol,Calcium carbonate, Yeast, hydroxyapatite, acacia senegal gum extract, sodium coco sulfate, hydrated silica, Mentha arvensis leaf oil, magnesium stearate, limonene, mentha viridis leaf oil, stevioside, menthol, mentha piperita oil

TOOTH 
toothpaste tablets tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83861-004
Route of Administration	PERIODONTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM COCO-SULFATE (UNII: 3599J29ANH)
YEAST (UNII: 3NY3SM6B8U)
ACACIA SENEGAL GUM (UNII: 5C5403N26O)
MENTHOL (UNII: L7T10EIP3A)
STEVIOSIDE (UNII: 0YON5MXJ9P)
MENTHA VIRIDIS (SPEARMINT) LEAF OIL (UNII: C3M81465G5)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYDROXYAPATITE (UNII: 91D9GV0Z28)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	9mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83861-004-01	2 in 1 BAG	12/25/2024
1		0.4 g in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/25/2024	01/03/2025

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(83861-004)

Revised: 1/2025

Document Id: 2ac88ff5-7872-0646-e063-6394a90a7001

34390-5

Set id: 2a140fee-88cb-8a9d-e063-6394a90a01ef

Version: 2

Effective Time: 20250103