HAIR-REGEN HAIR GROWTH TREATMENT- minoxidil liquid

Hair-Regen Hair Growth Treatment by

Drug Labeling and Warnings

Hair-Regen Hair Growth Treatment by is a Otc medication manufactured, distributed, or labeled by Yiwu Yizhou Trading Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Minoxidil 5% w/v

Purpose

Hair Regrowth Treatment

USE

to regrow hair on top of scalp (vertex only, see pictures on side of box)

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame.

Do not use if ...

• You are a woman.
• Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
• You have no family history of hair loss.
• Your hair loss is sudden and/or patchy.
• You do not know the reason for your hair loss.
• You are under 18 years of age. Do not use on babies and children.
• Your scalp is red, inflamed, infected, rritated, or painful.
• You use other medicines on the scalp.

ASK DOCTOR

Ask your doctor before use if you have any symptoms and warning signs of heart disease.

When using this product ...

• Do not apply on other parts of your body.
• Avoid contact with the eyes. In case of accidental contact, rinse eyes with cool tap water.
• Some people have experienced changes in hair color and/or texture.
• It takes time to regrow hair, results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
• The amount of hair regrowth is different for each person. This product will not work on all men.

Stop use and ask doctor if ...

• Chest pain, rapid heartbeat, faintness, or dizziness occurs
• Sudden, unexplained weight gain occurs
• Your hands or feet swell
• Scalp rritation or redness occurs
• Unwanted facial hair growth occurs
• You do not see hair growth in 4 months

KEEP OUT OF REACH OF CHILDREN

Do not use it on babies and children.

Directions

• Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area.
• Using more or more often will not improve results.
• Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

Other information

• See hair loss pictures on side of box.
• Before use, read all information on box and enclosed instructions.
• Keep the box, it contains important information.
• Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical sol ution 5% for men.
• In Clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
• Store at 20 to 25℃ (68 to 77℉). Keep cap tightly closed.

STORAGE AND HANDLING

Store at 20 to 25℃ (68 to 77℉). Keep cap tightly closed.

Inactive Ingredients

alcohol, propylene glycol, purified water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAIR-REGEN HAIR GROWTH TREATMENT 
minoxidil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84232-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84232-011-26	6 in 1 BOX	06/28/2024
1	NDC: 84232-011-02	60 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/28/2024

Labeler - Yiwu Yizhou Trading Co., Ltd (840905001)

Registrant - Yiwu Yizhou Trading Co., Ltd (840905001)

Establishment
Name	Address	ID/FEI	Business Operations
Yiwu Yizhou Trading Co., Ltd		840905001	manufacture(84232-011)