XINGHUI CELL EXOSOME- stem cell exosome wound healing fluid powder, for solution

XINGHUI Cell Exosome by

Drug Labeling and Warnings

XINGHUI Cell Exosome by is a Otc medication manufactured, distributed, or labeled by Beijing Xinghui Regeneration Technology Co., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

XINGHUI Cell Exosome

ACTIVE INGREDIENT

ALLOGENEIC HUMAN UMBILICAL CORD-DERIVED MESENCHYMAL STEM CELLS

PURPOSE

PROMOTES HEALING OF WOUNDS.

EXTENDED PROTECTION.

SOOTHING TREATMENT

INDICATIONS & USAGE

wounds healing.

cuts, scrapes and abrasion

WARNINGS

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

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.

STORAGE AND HANDLING

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.

INACTIVE INGREDIENT

MANNITOL, HISTIDINAL,L-, POLYSORBATE 80, WATER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XINGHUI CELL EXOSOME 
stem cell exosome wound healing fluid powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83117-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLOGENIC ADIPOSE DERIVED MESENCHYMAL STEM CELLS (MSCS) EXOSOMES (UNII: 377D2SLL5Z) (ALLOGENIC ADIPOSE DERIVED MESENCHYMAL STEM CELLS (MSCS) EXOSOMES - UNII:377D2SLL5Z)	ALLOGENIC ADIPOSE DERIVED MESENCHYMAL STEM CELLS (MSCS) EXOSOMES	15 mg  in 3 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MANNITOL (UNII: 3OWL53L36A)
HISTIDINAL, L- (UNII: J7G22NER35)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83117-006-01	20 in 1 BOX	07/03/2023
1		3 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/03/2023

Labeler - Beijing Xinghui Regeneration Technology Co., LTD. (601026471)

Registrant - Beijing Xinghui Regeneration Technology Co., LTD. (601026471)

Establishment
Name	Address	ID/FEI	Business Operations
Beijing Xinghui Regeneration Technology Co., LTD.		601026471	manufacture(83117-006)