ECO WHITENING (HYDROGEN PEROXIDE) GEL [JN PHARM]

ECO WHITENING (HYDROGEN PEROXIDE) GEL [JN PHARM]
PDF | XML

NDC 62040-1001-1, 62040-1001-2
Set ID 6b6e6a38-2e62-47cb-a54e-a25c4feb2051
Category HUMAN OTC DRUG LABEL
Packager JN Pharm
Generic Name
Product Class
Product Number
Application Number
  • 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

    package label
  • INGREDIENTS AND APPEARANCE
    ECO WHITENING 
    hydrogen peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62040-1001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE8.57 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62040-1001-23 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/FEIBusiness Operations
    JN Pharm689048618manufacture(62040-1001)

Related Drugs