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

Image of carton

MONGDIES RASPBERRY BABY TOOTH 
silicon dioxide paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70477-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Silicon Dioxide (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) Silicon Dioxide15.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
Xylitol (UNII: VCQ006KQ1E)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70477-080-021 in 1 CARTON09/01/202103/01/2022
1NDC:70477-080-01100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/202103/01/2022
Labeler - 360Perspective Inc. (689606142)
Registrant - 360Perspective Inc. (689606142)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(70477-080)

Revised: 5/2023
 
360Perspective Inc.