FDA.reportPublic FDA data

100 toothpast e Afternoon

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 23:00:32

Label at a glance#

Product100 toothpast e Afternoon
Active ingredientHYDROGEN PEROXIDE
Label structure8 sections

Indications and uses

■ Effectively cleans and polishes away stains for brighter teeth. ■ Restores the natural whiteness of your teeth.

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 only 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

HYDROGEN PEROXIDE 2.14%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aqua, Concentrated Glycerin, Colloidal Silicon Dioxide, Sodium Cocoyl Glutamate, Xanthangum, L-Menthol, Mint Flavor, Cassis Orange Flavor Grapefruit Seed Extract, Xylitol, Enzymatically Modified Stevia, Green Tea Extract, Aloe Extract, Eucalyptus Extract, Chamomile Extract, Sage Extract

PURPOSE

OTC - PURPOSE SECTION

Whitening

WARNINGS

WARNINGS SECTION

Adults and children 2 years of age and older: apply a 1-inch strip of product onto a toothbrush. Brush teeth thoroughly for 3 minutes three times a day (morning, afternoon, evening) or as recommended by a dentist. Do not swallow.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

■ Effectively cleans and polishes away stains for brighter teeth.
■ Restores the natural whiteness of your teeth.

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 only 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
81307-020-022024-12-26C16284748780-1f386c649-f7fa-0266-e053-dadaa90a7c1ae1f53868-cdba-49d3-9ab7-1cee33a78268
81307-020-022023-01-30C16284748780-1f386c649-f7fa-0266-e053-dadaa90a7c1ae1f53868-cdba-49d3-9ab7-1cee33a78268

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
81307-02081307-020-01, 81307-020-02

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
HYDROGEN PEROXIDEBBX060AN9VACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Silicon DioxideETJ7Z6XBU4IACT

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
2a3713d3-5f33-bf99-e063-6294a90a8d6ae1f53868-cdba-49d3-9ab7-1cee33a782682024-12-26WarningsExact identifier
spl set id: e1f53868-cdba-49d3-9ab7-1cee33a78268

Reported adverse events (FAERS/openFDA)#

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