Mongdies Raspberry Baby Tooth: Package Insert and Label Information

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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Silicon Dioxide (SILICON DIOXIDE) Silicon Dioxide 15.0 g in 100 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL
Xylitol
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70477-080-02 1 TUBE in 1 CARTON contains a TUBE (70477-080-01)
1 NDC:70477-080-01 100 g in 1 TUBE This package is contained within the CARTON (70477-080-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2021
Labeler — 360Perspective Inc. (689606142)
Registrant — 360Perspective Inc. (689606142)
Establishment
Name Address ID/FEI Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory 689512611 manufacture (70477-080)

Revised: 09/2021 360Perspective Inc.

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