Otc - Active Ingredient
Hydrogen Peroxide
Eco Whitening
FDA Label NDC 62040-1001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jn Pharm for the product Eco Whitening (NDC 62040-1001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Polyvinylpyrrolidone, Ethanol, Glycerin, Dipotassium Glycyrrhizate, Polyoxyethylene Hydrogenated Castor Oil, Methylparaben, sodium Saccharin, Mentha oil, Purified water
Otc - Purpose
teeth whitening
Otc - 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
* Please review the disclaimer below.
