HAIR REGEN - HAIR REGROWTH TREATMENT- mens foam minoxidil 1 pk aerosol, foam

Hair Regen - Hair Regrowth Treatment by

Drug Labeling and Warnings

Hair Regen - Hair Regrowth 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 Ingredient

Minoxidil 5% w/w (without propellant)

Purpose

Hair regrowth treatment for men

Use

to regrow hair on top of the scalp (vertex only, see pictures on side of this carton)

Warnings

For external use only. For use by men only.

Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

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. 5% minoxidil topical foam 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, irritated, or painful.
• you use other medicines on the scalp.

Ask a doctor before use

if you have 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 large amounts of 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 for all men.

Stop use and ask a doctor if

• chest pain, rapid heartbeat, faintness, or dizziness occurs.
• sudden, unexplained weight gain occurs.
• your hands or feet swell.
• scalp irritation or redness occurs.
• unwanted facial hair growth occurs.
• you do not see hair growth in 4 months.

May be harmful if used when pregnant or breast-feeding.

Keep out of reach of children.

If swallowed, get medical helf or contact a Poison Control Center right away.

Directions

• apply half a capful 2 times a day to the scalp in the hair loss area.
• massage into scalp with fingers, then wash hands well.
• see enclosed booklet for complete directions on how to use.
• 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

• hair regrowth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months.
• see hair loss pictures on side of this carton.
• before use, read all information on package and enclosed booklet.
• keep the package. It contains important information.

STORAGE AND HANDLING

Store at controlled room temperature 68 to 77℉ (20 to 25℃).

Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperaures above 120℉ (49℃).

Inactive ingredients

butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol 40-B, stearyl alcohol.

PRINCIPAL DISPLAY PANEL

M13:

M-02:

INGREDIENTS AND APPEARANCE

HAIR REGEN - HAIR REGROWTH TREATMENT 
mens foam minoxidil 1 pk aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84232-012
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 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
BUTANE (UNII: 6LV4FOR43R)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPANE (UNII: T75W9911L6)
LACTIC ACID (UNII: 33X04XA5AT)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISOBUTANE (UNII: BXR49TP611)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84232-012-21	1 in 1 BOX	04/15/2025
1	NDC: 84232-012-02	60 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/15/2025

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(84232-012)