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

Hairstem Cell Exosomes by

Drug Labeling and Warnings

Hairstem Cell Exosomes by is a Otc medication manufactured, distributed, or labeled by Beijing Xinghui Regeneration Technology Co., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HAIRSTEM CELL EXOSOMES 
stem cell germinal fluid powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83117-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 CELLS	15 mg  in 3 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83117-005-02	20 in 1 BOX	12/23/2022
1		3 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/23/2022

Labeler - Beijing Xinghui Regeneration Technology Co., LTD. (601026471)

Registrant - Beijing Xinghui Regeneration Technology Co., LTD. (601026471)

Establishment
Name	Address	ID/FEI	Business Operations
Beijing Xinghui Regeneration Technology Co., LTD.		601026471	manufacture(83117-005)