[De-listing 400-20] CURESTEM CELL HEALER C10 PROGRAM : 78521-400-20

CURESTEM CELL HEALER C10 PROGRAM by

Drug Labeling and Warnings

CURESTEM CELL HEALER C10 PROGRAM by is a Otc medication manufactured, distributed, or labeled by DNK CORPORATION LTD., Shinsegae Intercos Korea Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CURESTEM CELL HEALER C10 PROGRAM- mannitol, panthenol 
DNK CORPORATION LTD.

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.

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[De-listing 400-20] CURESTEM CELL HEALER C10 PROGRAM : 78521-400-20

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 C10'

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

CURESTEM CELL HEALER C10 PROGRAM1) CURESTEM CELL HEALER C10 CURESTEM SKIN RELAXER

CURESTEM CELL HEALER C10 PROGRAM 
mannitol, panthenol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78521-400
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78521-400-201 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 C10 
mannitol powder
Product Information
Item Code (Source)NDC: 78521-300
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: 78521-300-1010 in 1 BOX
1NDC: 78521-300-012 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 other06/05/202006/08/2020
Labeler - DNK CORPORATION LTD. (695538778)
Establishment
NameAddressID/FEIBusiness Operations
Shinsegae Intercos Korea Inc.694526100manufacture(78521-200, 78521-300, 78521-400)

Revised: 6/2020
 

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