Mongdies spearmint adult tooth by 360Perspective Inc. / Kolmar Korea Co.,LTD. Gwanjeong Factory

Mongdies spearmint adult tooth by

Drug Labeling and Warnings

Mongdies spearmint adult tooth by is a Otc medication manufactured, distributed, or labeled by 360Perspective Inc., Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MONGDIES SPEARMINT ADULT TOOTH- sodium monofluorophosphate paste, dentifrice 
360Perspective Inc.

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.

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ACTIVE INGREDIENT

Sodium Monofluorophosphate 0.6%

PURPOSE

Anti-plaque

WARNINGS

1. For adults only. 2. Be careful not to swallow, and rinse mouth thoroughly after use. 3. If any abnormality occurs such as gums or mouth injuries with this toothpaste, discontinue use and consult a doctor or dentist.4. If a child under the age of 7 swallows a large amount, consult a doctor or dentist immediately. 5. Keep out of the reach of children under 7 years of age.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 7 years of age.

Uses

It Keeps teeth white and firm. It Keeps the mouth clean and refresh the inside of the mouth. It prevents the cavity and removes the bad breath. It Increases the aesthetic effect. Removing plaque (anti-plaque), Prevention of gingivitis, periodontitis (gingivitis), periodontal disease, gum disease.

Directions

Apply a proper amount of toothpaste to the toothbrush and brush your teeth.

INACTIVE INGREDIENTS

Silicon Dioxide, Sodium pyrophosphate, Pyridoxine hydrochloride, L-Menthol, glycerin, Camellia sinensis leaf extract, Rosemary extract, Mastic, Cellulose gum, Sodium methyl cocoyl taurate, Sorbitol solution, PARFUM, Sodium Chloride, Xylitol, Purified water, Calendula extract, Chamomile extract, Peppermint oil, Propolis extract, Scutellaria Baicalensis root extract, Enzyme treatment Stevia

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MONGDIES SPEARMINT ADULT TOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70477-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium pyrophosphate (UNII: O352864B8Z)
Pyridoxine hydrochloride (UNII: 68Y4CF58BV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70477-060-02	1 in 1 CARTON	09/01/2021	03/01/2022
1	NDC: 70477-060-01	100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/01/2021	03/01/2022

Labeler - 360Perspective Inc. (689606142)

Registrant - 360Perspective Inc. (689606142)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(70477-060)

Revised: 5/2023

Document Id: 673635ae-8f70-4534-888e-bc31207aae26

34390-5

Set id: 32f46a69-29e2-4a4d-9a37-93bf55f56cf9

Version: 2

Effective Time: 20230518