Hairstem Cell Exosomes

Manufacturer
Beijing Xinghui Regeneration Technology Co., LTD.
Effective date
2023-04-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:39

Label at a glance#

ProductHairstem Cell Exosomes
Active ingredientALLOGENEIC HUMAN UMBILICAL CORD-DERIVED MESENCHYMAL STEM CELLS
Label structure11 sections

Storage and handling

Agent I: Keep away from light, refrigerate at low temperature, and use it within 24 hours after opening. Agent II: Can be stored at room temperature or low temperature.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ALLOGENEIC HUMAN UMBILICAL CORD-DERIVED MESENCHYMAL STEM CELLS (MSCS) EXOSOMES.

WARNINGS SECTION

1.In the process of using this product, if the application site has abnormal symptoms or side effects such as erythema, redness, swelling or itching due to direct light, seek medical advice and consult a professional doctor immediately.
2.Avoid using it on wounds.
3.Keep the product out of reach of children.
4.If it accidentally gets into the eyes, immediately wash and flush eyes with clean water.
5.This product may cause skin and body allergies or aggravate existing abnormal skin reactions (edema, inflammation, etc.). If you have experienced prior allergic reactions, consult a professional doctor or pharmacist before use.

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.

OTC - PURPOSE SECTION

Improves effects of hair elasticity

OTC - STOP USE SECTION

Stop use and ask a doctor if erythema, redness, swelling or itching develops.

DOSAGE & ADMINISTRATION SECTION

Mix agent I with agent Ⅱ, after completely dissolving, gently apply an appropriate amount to the scalp, focusing on the key areas.

Once every three days.

OTC - DO NOT USE SECTION

• If you are pregnant or have the possibility of pregnancy
• If you are breastfeeding
• If you are under the age of three

STORAGE AND HANDLING SECTION

Agent I: Keep away from light, refrigerate at low temperature, and use it within 24 hours after opening. Agent II: Can be stored at room temperature or low temperature.

INDICATIONS & USAGE SECTION

Improves effects of hair elasticity.

Mix agent Ⅰwith agent Ⅱ, after completely dissolving, gently apply an appropriate amount to the scalp, focusing on the key areas.

INACTIVE INGREDIENT SECTION

water, mannitol, L-histidine, Tween-80

20bottle in 1 box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20 bottle in 1 box20 bottle in 1 box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83117-005-022025-01-30C16284748780-11030e365-19ca-111a-e063-dadaa90a10e2Stem Cell Germinal Fluid
83117-005-022024-01-30C16284748780-11030e365-19ca-111a-e063-dadaa90a10e2Stem Cell Germinal Fluid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83117-005-02Hairstem Cell Exosomes3 mL in 1 BOTTLEPOWDER, FOR SOLUTION32
83117-005-02Hairstem Cell Exosomes20 in 1 BOXPOWDER, FOR SOLUTION202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83117-005HAIRSTEM CELL EXOSOMES (STEM CELL GERMINAL FLUID) POWDER, FOR SOLUTION [BEIJING XINGHUI REGENERATION TECHNOLOGY CO., LTD.]2Legacy NDC, 2 package rows20230407_f0520969-8f9b-e679-e053-2a95a90ac9ad.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
83117-00583117-005-02

Ingredients#

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

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

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
f8ab1161-ee22-e62a-e053-6394a90a35cbf0520969-8f9b-e679-e053-2a95a90ac9ad2023-04-06WarningsExact identifier
spl id: f8ab1161-ee22-e62a-e053-6394a90a35cb
spl set id: f0520969-8f9b-e679-e053-2a95a90ac9ad

Reported adverse events (FAERS/openFDA)#

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