FDA.reportPublic FDA data

ALLOGENIC ADIPOSE DERIVED MESENCHYMAL STEM CELLS (MSCS) EXOSOMES

Manufacturer
Beijing Xinghui Regeneration Technology Co., LTD.
Effective date
2023-07-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:55:41

Label at a glance#

ProductXINGHUI Cell Exosome
Active ingredientALLOGENIC ADIPOSE DERIVED MESENCHYMAL STEM CELLS (MSCS) EXOSOMES
Label structure13 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

XINGHUI Cell Exosome

OTC - ACTIVE INGREDIENT SECTION

ALLOGENEIC HUMAN UMBILICAL CORD-DERIVED MESENCHYMAL STEM CELLS

OTC - PURPOSE SECTION

PROMOTES HEALING OF WOUNDS.

EXTENDED PROTECTION.

SOOTHING TREATMENT

INDICATIONS & USAGE SECTION

wounds healing.

cuts, scrapes and abrasion

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

Erythema, redness, swelling, or itching develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

MANNITOL, HISTIDINAL,L-, POLYSORBATE 80, WATER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label-1label-1

label-2label-2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83117-006-012025-01-30C16284748780-11030e365-4311-111a-e063-dadaa90a10e2XINGHUI Cell Exosome
83117-006-012024-01-30C16284748780-11030e365-4311-111a-e063-dadaa90a10e2XINGHUI Cell Exosome

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83117-006-01XINGHUI Cell Exosome3 mL in 1 BOTTLEPOWDER, FOR SOLUTION35
83117-006-01XINGHUI Cell Exosome20 in 1 BOXPOWDER, FOR SOLUTION205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83117-006XINGHUI CELL EXOSOME (STEM CELL EXOSOME WOUND HEALING FLUID) POWDER, FOR SOLUTION [BEIJING XINGHUI REGENERATION TECHNOLOGY CO., LTD.]52 package rows20230721_ff9090cf-b911-da07-e053-6394a90a9936.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83117-00683117-006-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALLOGENIC ADIPOSE DERIVED MESENCHYMAL STEM CELLS (MSCS) EXOSOMES377D2SLL5ZACTIB
MANNITOL3OWL53L36AIACT
HISTIDINAL, L-J7G22NER35IACT
POLYSORBATE 806OZP39ZG8HIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
00f73071-8930-7a73-e063-6294a90a981cff9090cf-b911-da07-e053-6394a90a99362023-07-20WarningsExact identifier
spl id: 00f73071-8930-7a73-e063-6294a90a981c
spl set id: ff9090cf-b911-da07-e053-6394a90a9936

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.