Label: GENGICURE- hyaluronic acid gel

  • NDC Code(s): 82160-566-01
  • Packager: Pella Pharmaceuticals Co. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 6, 2021

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  • Forms and Presentation

    Gel: Tube 15 g

  • Active Ingredient

    Hyaluronic Acid

  • Inactive Ingredients

    Aqua, Hydroxypropyl Cellulose, Sodium Benzoate and Dichlorobenzyl Alcohol.

  • Purpose

    Helps healing internal and external mouth ulcers and relieving pain

  • Properties

    gengicure® gel has a special formula immediately reduces pain and promotes the treatment of oral mucosal ulcers by accelerating normal healing process because it contains hyaluronic acid, a natural substance found in the connective tissues of the body. When applied to the ulcers it stimulates the production of new healthy tissue.
    Paraben Free
    Sugar Free
    Colorants Free

  • Indication

    gengicure ®gel helps healing internal and external mouth ulcers and relieving pain

  • Precautions

    Keep out of reach of children

  • Warnings

    • Do not swallow the product
    • If symptoms persist consult your doctor
  • Contraindication

    • Hypersensitivity to any of the components
    • Do not use for children under 2 years
  • Pregnancy and Lactation

    Ask your doctor or pharmacist for advice before using any product.
    If you want to apply the gel during pregnancy or lactation then discuss this with your doctor

  • Interactions

    No interactions between gengicure ® gel and other drugs or substances are known or suspected.

  • Side effects

    There are no known side effects

  • Dosage and administration

    Apply a film of gel onto affected area only, massaging gently with clean fingers to aid its correct distribution and then keep it to dry for 30 – 60 seconds.
    Apply 2-3 times daily, for one week or until the symptoms disappear.
    It is advisable not to eat or drink for at least 30 minutes after application.

  • Storage Conditions

    Store below 30 ◦C.

  • Primary Package

    Primary Package

  • Secondary Package

    Secondary Package

  • INGREDIENTS AND APPEARANCE
    GENGICURE 
    hyaluronic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-566
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONIC ACID0.3 mg  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    DICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82160-566-011 in 1 CARTON01/15/2020
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/15/2020
    Labeler - Pella Pharmaceuticals Co. Ltd (562370925)
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