Minoxidil 5% For Hair Regen Mens Foam Minoxidil 1 Pk

Minoxidil 5% For Hair Regen Mens Foam Minoxidil 1 Pk
SPL v1
SPL
SPL Set ID 32ba7d88-c8ff-fac6-e063-6294a90a7c65
Route
TOPICAL
Published
Effective Date 2025-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Glycerin Butane Water Alcohol Propane Lactic Acid Polysorbate 60 Isobutane Stearyl Alcohol Cetyl Alcohol Butylated Hydroxytoluene Citric Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-04-15

Description

Minoxidil 5% w/w (without propellant)

Purpose

Hair regrowth treatment for men


Medication Information

Purpose

Hair regrowth treatment for men

Description

Minoxidil 5% w/w (without propellant)

Use

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

Section 44425-7

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℃).

Section 51945-4

M13:

M-02:

Warnings

For external use only. For use by men only.

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

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.
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.
Active Ingredient

Minoxidil 5% w/w (without propellant)

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.
Inactive Ingredients

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

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.
Keep Out of Reach of Children.

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


Structured Label Content

Use

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

Section 44425-7 (44425-7)

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℃).

Section 51945-4 (51945-4)

M13:

M-02:

Purpose

Hair regrowth treatment for men

Warnings

For external use only. For use by men only.

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

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.
Do Not Use If (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.
Active Ingredient

Minoxidil 5% w/w (without propellant)

Other Information (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.
Inactive Ingredients (Inactive ingredients)

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

Ask A Doctor Before Use (Ask a doctor before use)

if you have heart disease

When Using This Product (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 (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.
Keep Out of Reach of Children. (Keep out of reach of children.)

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


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