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Eco Whitening

Medically reviewed on February 8, 2018

Dosage form: gel
Ingredients: HYDROGEN PEROXIDE 8.57g in 100mL
Labeler: JN Pharm
NDC Code: 62040-1001

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.

Drug Facts

Hydrogen Peroxide



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


teeth whitening


keep out or reach of the children


-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

*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.


dental use only


ECO WHITENING 
hydrogen peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62040-1001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE8.57 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
GLYCYRRHIZINATE DIPOTASSIUM 
Packaging
#Item CodePackage Description
1NDC:62040-1001-23 BOTTLE, PLASTIC (BOTTLE) in 1 PACKAGE
1NDC:62040-1001-12 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/08/2014
Labeler - JN Pharm (689048618)
Registrant - JN Pharm (689048618)
Establishment
NameAddressID/FEIOperations
JN Pharm689048618manufacture(62040-1001)

 
JN Pharm

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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