Label: HAIRSTEM CELL EXOSOMES- stem cell germinal fluid powder, for solution

  • NDC Code(s): 83117-005-02
  • Packager: Beijing Xinghui Regeneration Technology Co., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 6, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

  • WARNINGS

    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.

  • KEEP OUT OF REACH OF CHILDREN

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

  • PURPOSE

    Improves effects of hair elasticity

  • STOP USE

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

  • DOSAGE & ADMINISTRATION

    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.

  • DO NOT USE

    • 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

    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

    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

    water, mannitol, L-histidine, Tween-80

  • 20bottle in 1 box

    20 bottle in 1 box

  • INGREDIENTS AND APPEARANCE
    HAIRSTEM CELL EXOSOMES 
    stem cell germinal fluid powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83117-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLOGENEIC HUMAN UMBILICAL CORD-DERIVED MESENCHYMAL STEM CELLS (UNII: G64F59W88V) (ALLOGENEIC HUMAN UMBILICAL CORD-DERIVED MESENCHYMAL STEM CELLS - UNII:G64F59W88V) ALLOGENEIC HUMAN UMBILICAL CORD-DERIVED MESENCHYMAL STEM CELLS15 mg  in 3 mL
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A) 0.135 mL  in 3 mL
    WATER (UNII: 059QF0KO0R) 2.85 mL  in 3 mL
    HISTIDINAL, L- (UNII: J7G22NER35) 0.009 mL  in 3 mL
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.006 mL  in 3 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83117-005-0220 in 1 BOX12/23/2022
    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 other12/23/2022
    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(83117-005)