5% Minoxidil Hair Regrowth Foam

5% Minoxidil Hair Regrowth Foam
SPL v1
SPL
SPL Set ID 28fc8b76-ec7f-f4be-e063-6394a90a11f7
Route
TOPICAL
Published
Effective Date 2024-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g) Biotin (0.5 g)
Inactive Ingredients
Lactic Acid .alpha.-tocopherol Cetyl Alcohol Alcohol Stearyl Alcohol Glycerin Polysorbate 80 Anhydrous Citric Acid Castor Oil Edetate Disodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-11

Description

5% Minoxidil Hair Regrowth Foam


Medication Information

Warnings and Precautions

For external use only. For use by men only.

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

Indications and Usage

Use to regrow hair on the top of the scalp

Dosage and Administration

See enclosed leaflet for complete directions on how to use.

Apply half a capful twice daily directly to the scalp in the hair lossarea.

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 regrowthor hair loss will begin again.

Description

5% Minoxidil Hair Regrowth Foam

Section 42229-5

5% Minoxidil Hair Regrowth Foam

Section 44425-7

Before use, read all information on carton and enclosed leaflet

Store at controlled room temperature 20° to 25°C (68° to 77°F).

Do not incinerate container. Do not expose to heat or store attemperature above 120°F(49°C).

Section 50565-1

lf swallowed, get medical help or contact a Poison ControlCenter right away.(1-800-222-1222)right away.

Section 50566-9

if chest pain, rapid heartbeat, faintness, or dizziness occurs.

if sudden, unexplained weight gain occurs.

if your hands or feet swell.

if scalp irritation or redness occurs.

if unwanted facial hair growth occurs.

if you do not see hair regrowth in 6 months.

Section 50567-7

Do not apply on other parts of the body.

Avoid contact with the eyes. in case of accidental contact, rinseeyes with large amounts of cool tap water.

Some people have experienced changes in hair color and,;or textureit takes time to regrow hair, Results may occur at 3 months withtwice a day usage. For some men, you may need to use this productfor at least 6 months before you see results.

The amount of hair regrowth is different for each person.This product will not work for all men.

Section 50570-1

you are a woman.

your amount of hair loss is different than that shown on side ofthis carton or your hair loss is on the front of the scalp.5% minoxidilfoam is not intended for frontal baldness or receding hairline.

You have no family history of hair loss.

Your hair loss is sudden andjor 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.

You use other medicines on the scalp.

Your scalp is red, inflamed, infected, irritated, or painful.

Section 51727-6

ALCOHOL

GLYCERIN

CETYL ALCOHOL

STEARYL ALCOHOL

POLYSORBATE 80

ANHYDROUS CITRIC ACID

LACTIC ACID

CASTOR OIL

.ALPHA.-TOCOPHEROL

EDETATE DISODIUM

WATER

Section 51945-4

Section 55105-1

Hair regrowth treatment

Section 55106-9

Minoxidil 5%

Biotin 0.5%


Structured Label Content

Indications and Usage (34067-9)

Use to regrow hair on the top of the scalp

Dosage and Administration (34068-7)

See enclosed leaflet for complete directions on how to use.

Apply half a capful twice daily directly to the scalp in the hair lossarea.

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 regrowthor hair loss will begin again.

Warnings and Precautions (34071-1)

For external use only. For use by men only.

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

Section 42229-5 (42229-5)

5% Minoxidil Hair Regrowth Foam

Section 44425-7 (44425-7)

Before use, read all information on carton and enclosed leaflet

Store at controlled room temperature 20° to 25°C (68° to 77°F).

Do not incinerate container. Do not expose to heat or store attemperature above 120°F(49°C).

Section 50565-1 (50565-1)

lf swallowed, get medical help or contact a Poison ControlCenter right away.(1-800-222-1222)right away.

Section 50566-9 (50566-9)

if chest pain, rapid heartbeat, faintness, or dizziness occurs.

if sudden, unexplained weight gain occurs.

if your hands or feet swell.

if scalp irritation or redness occurs.

if unwanted facial hair growth occurs.

if you do not see hair regrowth in 6 months.

Section 50567-7 (50567-7)

Do not apply on other parts of the body.

Avoid contact with the eyes. in case of accidental contact, rinseeyes with large amounts of cool tap water.

Some people have experienced changes in hair color and,;or textureit takes time to regrow hair, Results may occur at 3 months withtwice a day usage. For some men, you may need to use this productfor at least 6 months before you see results.

The amount of hair regrowth is different for each person.This product will not work for all men.

Section 50570-1 (50570-1)

you are a woman.

your amount of hair loss is different than that shown on side ofthis carton or your hair loss is on the front of the scalp.5% minoxidilfoam is not intended for frontal baldness or receding hairline.

You have no family history of hair loss.

Your hair loss is sudden andjor 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.

You use other medicines on the scalp.

Your scalp is red, inflamed, infected, irritated, or painful.

Section 51727-6 (51727-6)

ALCOHOL

GLYCERIN

CETYL ALCOHOL

STEARYL ALCOHOL

POLYSORBATE 80

ANHYDROUS CITRIC ACID

LACTIC ACID

CASTOR OIL

.ALPHA.-TOCOPHEROL

EDETATE DISODIUM

WATER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair regrowth treatment

Section 55106-9 (55106-9)

Minoxidil 5%

Biotin 0.5%


Advanced Ingredient Data


Raw Label Data

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