Mongdies raspberry baby tooth by 360Perspective Inc. / Kolmar Korea Co.,LTD. Gwanjeong Factory

Mongdies raspberry baby tooth by

Drug Labeling and Warnings

Mongdies raspberry baby 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 RASPBERRY BABY TOOTH- silicon dioxide paste, dentifrice 
360Perspective Inc.

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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ACTIVE INGREDIENT

Silicon Dioxide 15%

PURPOSE

Anti-plaque

WARNINGS

1. For babies under 3 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 rice sized amount and gently brush baby’s teeth.

INACTIVE INGREDIENTS

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, Orange Oil, Raspberry Flavor HF-AF11842, Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MONGDIES RASPBERRY BABY TOOTH 
silicon dioxide paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70477-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Silicon Dioxide (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	Silicon Dioxide	15.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
Xylitol (UNII: VCQ006KQ1E)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70477-080-02	1 in 1 CARTON	09/01/2021	03/01/2022
1	NDC: 70477-080-01	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
unapproved drug other		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(70477-080)

Revised: 5/2023

Document Id: 409fd8e2-1db1-460e-a909-c533972e7da8

34390-5

Set id: bd64c95e-029f-4440-9729-e33a08ce5d61

Version: 2

Effective Time: 20230518