Minoxidil 5% For Hair Regen Womens Foam Minoxidil 1 Pk

Minoxidil 5% For Hair Regen Womens Foam Minoxidil 1 Pk
SPL v1
SPL
SPL Set ID 32ba9c8b-3af0-0731-e063-6294a90aa7b4
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 Lactic Acid Polysorbate 60 Isobutane Stearyl Alcohol Propane 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


Medication Information

Purpose

Hair regrowth treatment

Description

Minoxidil 5% w/w (without propellant)

Use

for women who have general thinning of hair on top of the scalp (vertex only, as shown below).

Section 44425-7

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

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

Section 51945-4

W17:

W-01:

Warnings

For external use only. For use by men only.

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

Directions
  • see enclosed booklet for complete directions.
  • apply half a capful once daily directly to the scalp in the hair loss area.
  • massage into scalp with fingers, then wash hands well.
  • 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
  • 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)

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 use more than directed.
  • do not apply on other parts of the 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.
  • results may occur at three months with consistent daily use. For some women, you may need to use this product once a day for at least six months before you see results.
  • the amount of hair regrowth is different for each person. This product will not work for all women.
Keep Out of Reach of Children.

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

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.

Structured Label Content

Use

for women who have general thinning of hair on top of the scalp (vertex only, as shown below).

Section 44425-7 (44425-7)

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

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)

W17:

W-01:

Purpose

Hair regrowth treatment

Warnings

For external use only. For use by men only.

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

Directions
  • see enclosed booklet for complete directions.
  • apply half a capful once daily directly to the scalp in the hair loss area.
  • massage into scalp with fingers, then wash hands well.
  • 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)
  • 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)

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 use more than directed.
  • do not apply on other parts of the 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.
  • results may occur at three months with consistent daily use. For some women, you may need to use this product once a day for at least six months before you see results.
  • the amount of hair regrowth is different for each person. This product will not work for all women.
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.

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.

Advanced Ingredient Data


Raw Label Data

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