Label: HYALURONIC ACID GEL- sodium hyaluronate gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 Label Information

Updated April 16, 2016

If you are a consumer or patient please visit this version.

  • Uses

    helps to prevent wrinkles and expression lines with inmediate results. It has a great ability to restore and maintain a high level of skin hydration. Provides a greater elasticity to skin.

    . temporarily protects against damage structures by improving cells water levels.

  • Warnings

    For external use only.

    Do not use on the following cases: damaged or broken skin, eczema and scalp wounds.

    Do not use if irritation occurs

    Avoid using on sensitive skins.

    When using this product keep our of the eyes. Rinse with water to remove.

    Keep out of reach of children.

    Children under 6 months: as a doctor.

    Keep out of reach of children.

  • Warnings

    Stop use and ask a doctor if rash occurs.

  • Questions or comments?

    + (35) 122 7347 125 M-F 9:00 am to 5:00 pm

  • Directions

    . apply 5 ml vial topically over the skin areas

  • Other information

    . if possible, avoid direct sunlight and stores in a cool area of low humidity. In order to maintain the quality of the product, avoid placing the product near fire and store out of the reach of children.

    . store in a cool place

  • Inactive ingredients

    water

    Back bottle

  • Directions

    . apply 5ml vial topically on the skin areas

  • Active Ingredients Purpose

    Active Ingredient Purpose

    Sodium Hyaluronate.................... Skin Protectant

    Front box

  • Uses

    . helps to prevent wrinkles and expression lines with inmediate results. It has a great ability to restore and maintain a high level of skin hydration. Provides a greater elasticity to skin.

    . temporarily protects against damage structures by improving cells water levels.

  • Principal Display Panel

    Hyaluronic Acid Gel

    Skin Protectant

  • Hyaluronic Acid Gel

    Skin Protectant
    Box

  • INGREDIENTS AND APPEARANCE
    HYALURONIC ACID GEL 
    sodium hyaluronate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70663-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM3.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 96.5 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70663-001-021 in 1 BOTTLE, PLASTIC04/15/2016
    1NDC:70663-001-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/15/2016
    Labeler - Meso System S.A. (768263100)
    Registrant - Meso System S.A. (768263100)
    Establishment
    NameAddressID/FEIBusiness Operations
    MESO SYSTEM S.A.768263100manufacture(70663-001)