Label: CURESTEM CELL HEALER C5 PROGRAM- mannitol, panthenol kit

  • NDC Code(s): 78521-100-01, 78521-100-10, 78521-200-01, 78521-200-10, view more
    78521-500-20
  • 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 ingredients

    [Powder] Mannitol 3%

    [Solvent] Panthenol 5%

  • Purpose

    [Powder] Mannitol 3% Skin Moisturizing

    [Solvent] Panthenol 5% 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

    Please use it after mixing 'SKIN RELAXER' into 'CELL HEALER C5'
    and shake it until it is completely dissolved.

  • Other information

    ■ Protect the product in this container from excessive heat and

    avoid storing it under direct sun.

    ■ Handle with care.

  • Inactive ingredients

    [Powder] Water, Human Cord Blood Cell Conditioned Media

    [Solvent] Water, Methylpropanediol, Propanediol, 1,2-Hexanediol,

    C12-14 Pareth-12, Tromethamine, Carbomer, Xanthan Gum,

    Ethylhexylglycerin, Pentylene Glycol, Disodium EDTA, Sodium Hyaluronate,

    Salvia Hispanica Seed Extract, Madecassoside, Houttuynia Cordata Extract,

    Centella Asiatica Extract, Hyaluronic Acid

  • PRINCIPAL DISPLAY PANEL

    C5 SKIN RELAXERCURESTEM CELL HEALER C5 PROGRAM

  • INGREDIENTS AND APPEARANCE
    CURESTEM CELL HEALER C5 PROGRAM 
    mannitol, panthenol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78521-500
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78521-500-201 in 1 BOX; Type 0: Not a Combination Product06/05/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL 2 mL
    Part 21 VIAL 5 mL
    Part 1 of 2
    CURESTEM CELL HEALER C5 
    mannitol powder
    Product Information
    Item Code (Source)NDC:78521-100
    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
    WATER (UNII: 059QF0KO0R)  
    CORD BLOOD (UNII: PVH8394DLN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78521-100-1010 in 1 BOX
    1NDC:78521-100-012 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
    Part 2 of 2
    CURESTEM SKIN RELAXER 
    panthenol liquid
    Product Information
    Item Code (Source)NDC:78521-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.25 g  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SALVIA HISPANICA SEED (UNII: NU0OLX06F8)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    C12-14 PARETH-12 (UNII: M0LJS773XW)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78521-200-1010 in 1 BOX
    1NDC:78521-200-015 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
    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(78521-100, 78521-200, 78521-500)