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XINGHUI Cell Exosome
Xinghui Cell Exosome
FDA Label NDC 83117-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beijing Xinghui Regeneration Technology Co., Ltd. for the product Xinghui Cell Exosome (NDC 83117-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
ALLOGENEIC HUMAN UMBILICAL CORD-DERIVED MESENCHYMAL STEM CELLS
Otc - 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.
Otc - 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
Package Label.Principal Display Panel
Label-1 (Label 1)
Label-2 (Label 2)
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