XINGHUI CELL EXOSOME- stem cell exosome wound healing fluid powder, for solution 
Beijing Xinghui Regeneration Technology Co., 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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XINGHUI Cell Exosome

XINGHUI Cell Exosome

ALLOGENEIC HUMAN UMBILICAL CORD-DERIVED MESENCHYMAL STEM CELLS

PROMOTES HEALING OF WOUNDS.

EXTENDED PROTECTION.

SOOTHING TREATMENT

wounds healing.

cuts, scrapes and abrasion

For external use only.
This product may cause skin and body allergies or aggravateexisting abnormal skin reactions (edema, inflammation, etc.).If youhave experienced prior allergic reactions, consult a professionaldoctor or pharmacist before use.

Do not use

lf you are pregnant or have the possibility of pregnancy

If you are breastfeeding

lf you are under the age of three

When using this product

Do not get into the eyes. lf it occurs, immediately wash andflush eyes with clean water.

Stop use and ask a doctor if

Erythema, redness, swelling, or itching develops.

Keep out of reach of children.
If swallowed, get medical help immediately, or contact a Poison Control Center.

Directions

Mix agentI(Powder) with agent Il(Solvent), after completelydissolving, gently apply an appropriate amount to the wound.focusing on the key areas.

Agent I(Powder): Keep away from light, refrigerate at lowtemperature, and use it within 24 hours after opening.

Agent ll(Solvent): Can be stored at room temperature or lowtemperature.

MANNITOL, HISTIDINAL,L-, POLYSORBATE 80, WATER

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XINGHUI CELL EXOSOME 
stem cell exosome wound healing fluid powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83117-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLOGENEIC HUMAN UMBILICAL CORD-DERIVED MESENCHYMAL STEM CELLS (UNII: G64F59W88V) (ALLOGENEIC HUMAN UMBILICAL CORD-DERIVED MESENCHYMAL STEM CELLS - UNII:G64F59W88V) ALLOGENEIC HUMAN UMBILICAL CORD-DERIVED MESENCHYMAL STEM CELLS15 mg  in 3 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MANNITOL (UNII: 3OWL53L36A)  
HISTIDINAL, L- (UNII: J7G22NER35)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83117-006-0120 in 1 BOX07/03/2023
13 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/03/2023
Labeler - Beijing Xinghui Regeneration Technology Co., LTD. (601026471)
Registrant - Beijing Xinghui Regeneration Technology Co., LTD. (601026471)
Establishment
NameAddressID/FEIBusiness Operations
Beijing Xinghui Regeneration Technology Co., LTD.601026471manufacture(83117-006)

Revised: 7/2023
 
Beijing Xinghui Regeneration Technology Co., LTD.