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

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 5, 2020

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  • 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)
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