Label: CURESTEM CELL HEALER C20- mannitol powder

  • NDC Code(s): 78521-020-01, 78521-020-10
  • Packager: DNK CORPORATION LTD.
  • 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 June 5, 2020

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

  • Active ingredient

    Mannitol 3%

  • Purpose

    Skin Moisturizing

  • Uses

    Helps skin moisture.

  • Warnings

    For external use only.

  • Do not use

    on injuries or wounds.

  • When using this product

    Avoid contact with eyes, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

  • Stop use and ask a doctor

    ■ if there are abnormal symptoms such as red blotches, swelling or itching.

    ■ if the above symptoms appear after exposure to direct sunlight.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ Lift the cap to open.
    ■ Hold the aluminum cap handle and pull it down to open.
    ■ Remove the aluminum cap by turning it to the side and then,
    open the rubber cap.
    ■ Mix 2 ml of normal saline or purified water and use it on the
    desired area (face or scalp).

  • Other information

    ■ Protect the product in this container from excessive heat and avoid storing it under direct sun.

    ■ Handle with care.

  • Inactive ingredients

    Water, Human Cord Blood Cell Conditioned Media

  • PRINCIPAL DISPLAY PANEL

    CURESTEM CELL HEALER C20

  • INGREDIENTS AND APPEARANCE
    CURESTEM CELL HEALER C20 
    mannitol powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78521-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A) MANNITOL0.06 g  in 2 mL
    Inactive Ingredients
    Ingredient NameStrength
    CORD BLOOD (UNII: PVH8394DLN)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78521-020-1010 in 1 BOX06/05/2020
    1NDC:78521-020-012 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/05/2020
    Labeler - DNK CORPORATION LTD. (695538778)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shinsegae Intercos Korea Inc.694526100manufacture(78521-020)