FDA.reportPublic FDA data

Mongdies raspberry baby tooth

Manufacturer
360Perspective Inc. | Kolmar Korea Co.,LTD. Gwanjeong Factory
Effective date
2021-09-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:36:40

Label at a glance#

ProductMongdies raspberry baby tooth
Active ingredientSilicon Dioxide
Label structure8 sections

Indications and uses

It keeps the mouth clean and refresh the inside of the mouth. It prevents the cavity and removes plaque.

Dosage and administration

Apply a rice sized amount and gently brush baby’s teeth.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Silicon Dioxide 15%

PURPOSE

OTC - PURPOSE SECTION

Anti-plaque

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

It keeps the mouth clean and refresh the inside of the mouth. It prevents the cavity and removes plaque.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a rice sized amount and gently brush baby’s teeth.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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 cartonImage of carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70477-08070477-080-01, 70477-080-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Silicon DioxideETJ7Z6XBU4ACTIB
SORBITOL506T60A25RIACT
XylitolVCQ006KQ1EIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
409fd8e2-1db1-460e-a909-c533972e7da8bd64c95e-029f-4440-9729-e33a08ce5d612023-05-18WarningsExact identifier
spl set id: bd64c95e-029f-4440-9729-e33a08ce5d61

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.