Mongdies blueberry kids tooth by 360Perspective Inc. / Kolmar Korea Co.,LTD. Gwanjeong Factory

Mongdies blueberry kids tooth by

Drug Labeling and Warnings

Mongdies blueberry kids 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 BLUEBERRY KIDS 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 0.38%

PURPOSE

Anti-plaque

WARNINGS

1. For kids between 4~10 years old. 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 the mouth clean and refresh the inside of the mouth. It prevents the cavity and removes plaque.

Directions

Apply a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.

INACTIVE INGREDIENTS

Silicon Dioxide, Precipitated Silica, D-Sorbitol Solution, Carboxymethylcellulose sodium, Xylitol, Steviol Glucoside, Sodium methyl cocoyl Taurate, Chitosan, Ascorbic Acid, Pyridoxine Hydrochloride, Rosemary Extract, Chamomile Extract(2), Strawberry Extract, Calendula Extract, Eucalyptus Oil, Blueberry Flavor HF-62686, Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MONGDIES BLUEBERRY KIDS TOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70477-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.38 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Silicon Dioxide (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
Xylitol (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70477-070-02	1 in 1 CARTON	09/01/2021	03/01/2022
1	NDC: 70477-070-01	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(70477-070)

Revised: 5/2023

Document Id: 26f153aa-8633-4938-96c0-6829d3c641f4

34390-5

Set id: 0836d8d1-d3f0-4c10-97f8-152a62a85c2c

Version: 2

Effective Time: 20230518