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

  • NDC Code(s): 83117-006-01
  • Packager: Beijing Xinghui Regeneration Technology Co., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 20, 2023

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  • 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

    label-1

    label-2

  • INGREDIENTS AND APPEARANCE
    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
    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) EXOSOMES15 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)
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