100 toothpast e Afternoon by MGRU / DONG IL PHARMS CO., LTD.

100 toothpast e Afternoon by

Drug Labeling and Warnings

100 toothpast e Afternoon by is a Otc medication manufactured, distributed, or labeled by MGRU, DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

100 TOOTHPAST E AFTERNOON- hydrogen peroxide gel, dentifrice 
MGRU

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

HYDROGEN PEROXIDE 2.14%

INACTIVE INGREDIENTS

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

Whitening

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

Uses

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

Directions

■ 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

100 TOOTHPAST E AFTERNOON 
hydrogen peroxide gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81307-020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	2.14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81307-020-02	1 in 1 CARTON	12/01/2020	12/31/2020
1	NDC: 81307-020-01	100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2020	12/31/2020

Labeler - MGRU (695672240)

Registrant - MGRU (695672240)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(81307-020)

Revised: 12/2024

Document Id: 2a3713d3-5f33-bf99-e063-6294a90a8d6a

34390-5

Set id: e1f53868-cdba-49d3-9ab7-1cee33a78268

Version: 2

Effective Time: 20241226

<