FDA.reportPublic FDA data

Teen Toothpast e Eucalyptus Flavor

Manufacturer
MGRU | DONG IL PHARMS CO., LTD.
Effective date
2020-12-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:00:09

Label at a glance#

ProductTeen Toothpast e Eucalyptus Flavor
Active ingredientSodium Monofluorophosphate
Label structure8 sections

Indications and uses

■ Helps fight and protect against cavities for healthier teeth. ■ Refreshes a day with eucalyptus flavor, which leaves the mouth feeling fresh and clean.

Dosage and administration

■ Adults and children 2 years of age and older: Brush teeth thoroughly. preferably .after each meal or three times a day, or as directed by a dentist or physician ■ Children 2 to 6 years: Use a pea sized amount and supervise child's brushing and rinsing. (to minimize swallowing) ■ Children under 2 years: Consult a dentist.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.758%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Precipitated Calcium Carbonate, D-Sorbitol Solution, Water, Hydroxyapatite, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xanthangum, Xylitol, Mint Flavor, L-Menthol, Eucalyptus Oil, Sodium Chloride, Grapefruit Seed Extract, Sage Extract, Aloe Extract, Eucalyptus Extract, Chamomile Extract, Green Tea Extract

PURPOSE

OTC - PURPOSE SECTION

Anti cavity

WARNINGS

WARNINGS SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

Uses

INDICATIONS & USAGE SECTION

■ Helps fight and protect against cavities for healthier teeth.
■ Refreshes a day with eucalyptus flavor, which leaves the mouth feeling fresh and clean.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 2 years of age and older: Brush teeth thoroughly. preferably .after each meal or three times a day, or as directed by a dentist or physician
■ Children 2 to 6 years: Use a pea sized amount and supervise child's brushing and rinsing. (to minimize swallowing)
■ Children under 2 years: Consult a dentist.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81307-040-022024-12-26C16284748780-1f386c64a-3105-0266-e053-dadaa90a7c1a3f680211-cb2a-4c43-8c54-bbd73c585b3d
81307-040-022023-01-30C16284748780-1f386c64a-3105-0266-e053-dadaa90a7c1a3f680211-cb2a-4c43-8c54-bbd73c585b3d

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81307-04081307-040-01, 81307-040-02

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
Sodium MonofluorophosphateC810JCZ56QACTIM
Calcium CarbonateH0G9379FGKIACT
Sorbitol506T60A25RIACT
Water059QF0KO0RIACT

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
2a373263-22e1-b1a2-e063-6394a90a1db63f680211-cb2a-4c43-8c54-bbd73c585b3d2024-12-26WarningsExact identifier
spl set id: 3f680211-cb2a-4c43-8c54-bbd73c585b3d

Reported adverse events (FAERS/openFDA)#

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