ECO WHITENING- hydrogen peroxide gel

Eco Whitening by

Drug Labeling and Warnings

Eco Whitening by is a Otc medication manufactured, distributed, or labeled by JN Pharm. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrogen Peroxide

INACTIVE INGREDIENT

Polyvinylpyrrolidone, Ethanol, Glycerin, Dipotassium Glycyrrhizate, Polyoxyethylene Hydrogenated Castor Oil, Methylparaben, sodium Saccharin, Mentha oil, Purified water

PURPOSE

teeth whitening

KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children

INDICATIONS & USAGE

-After getting rid of excess moisture on your teeth, apply a suitable amount of gel onto your teeth.
-Do not close your mouth until the gel is completely dried. (It takes about 30~60sec until it is evaporated).
-Rinse out with water after 30 minutes.
-Twice a day(in the morning and the evening), do the followings for two weeks

WARNINGS

*Be careful if you are with these troubles below.
-Allergic to hydrogen peroxide
-Infection in the mouth, damages on your teeth, gum diseases
-Teeth Calibration in progress

*Specific Caution :
-If you have a toothache, reduce the usage to once a day. If your toothache lasts   longer, stop using it for 2~3 days and start using it again.
-If gum diseases or intraoral troubles, stop using it.
-If you have a toothache continuously, then go to see a dentist.
-Use the appropriate amount of the product.
-Do not swallow.
-In case of accidental ingestion, seek professional assistance.
-When pregnant or lactating women use the product, check with a doctor before    using it.
-In case of the usage by kids under 12 years of age, seek for professional assistance first.
-While the gel is applied onto your teeth, do not eat, drink, smoke, or wash your face.
- Be careful not to make clothes to be stained with the gel.

DOSAGE & ADMINISTRATION

dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ECO WHITENING 
hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62040-1001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	8.57 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62040-1001-2	3 in 1 PACKAGE
1	NDC: 62040-1001-1	2 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/08/2014

Labeler - JN Pharm (689048618)

Registrant - JN Pharm (689048618)

Establishment
Name	Address	ID/FEI	Business Operations
JN Pharm		689048618	manufacture(62040-1001)