Active Ingredients And Purpose
Active Ingredient
Minoxidil 5% w/w (without propellant)
Purpose
Hair regrowth treatment for men
Hair Regen - Hair Regrowth Treatment
- Manufacturer
- Yiwu Yizhou Trading Co., Ltd
- Effective date
- 2025-04-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:59:07
Key Label Information#
Uses
Use
to regrow hair on top of the scalp (vertex only, see pictures on side of this carton)
Warnings
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
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.
Directions And Dosage
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 Label Information
STORAGE AND HANDLING SECTION
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
M15: M-02:
Label Images#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| MINOXIDIL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84232-014-02 | Hair Regen - Hair Regrowth Treatment | 60 g in 1 BOTTLE, DISPENSING | AEROSOL, FOAM | 60 | 1 | |
| 84232-014-26 | Hair Regen - Hair Regrowth Treatment | 6 in 1 BOX | AEROSOL, FOAM | 6 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
- Hair Regen - Hair Regrowth Treatment
- Mens foam Minoxidil 6 pk
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84232-014 | 84232-014-02, 84232-014-26 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| MINOXIDIL | 5965120SH1 | ACTIB |
| BUTANE | 6LV4FOR43R | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| LACTIC ACID | 33X04XA5AT | IACT |
| POLYSORBATE 60 | CAL22UVI4M | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| CITRIC ACID | 2968PHW8QP | IACT |
| PROPANE | T75W9911L6 | IACT |
| ISOBUTANE | BXR49TP611 | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | IACT |
Complete SPL Sections#
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 SECTION
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
M15: M-02: