[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 PROGRAM 
mannitol, panthenol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78521-400

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78521-400-20	1 in 1 BOX; Type 0: Not a Combination Product	06/05/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 VIAL	2 mL
Part 2	1 VIAL	5 mL

Part 1 of 2

CURESTEM CELL HEALER C10 
mannitol powder

Product Information
Item Code (Source)	NDC: 78521-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A)	MANNITOL	0.06 g  in 2 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CORD BLOOD (UNII: PVH8394DLN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78521-300-10	10 in 1 BOX
1	NDC: 78521-300-01	2 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/05/2020

Part 2 of 2

CURESTEM SKIN RELAXER 
panthenol liquid

Product Information
Item Code (Source)	NDC: 78521-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.25 g  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78521-200-10	10 in 1 BOX
1	NDC: 78521-200-01	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/05/2020	06/08/2020

Labeler - DNK CORPORATION LTD. (695538778)

Establishment
Name	Address	ID/FEI	Business Operations
Shinsegae Intercos Korea Inc.		694526100	manufacture(78521-200, 78521-300, 78521-400)

Revised: 6/2020

Document Id: a79ccc41-8e43-d023-e053-2995a90a44cb

34390-5

Set id: a752bb04-858f-8b87-e053-2a95a90a6252

Version: 2

Effective Time: 20200608