5% Minoxidil Hair Regrowth Foam

5% Minoxidil Hair Regrowth Foam
SPL v1
SPL
SPL Set ID 21e6def7-3716-3d91-e063-6294a90a817a
Route
TOPICAL
Published
Effective Date 2024-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-12

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 leallet for complete directions on howr to use.

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

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 abowe 120°F (49°C].

Section 50565-1

If 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 ofthe 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 ofthe 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 and/or patchy.

You do not knoww the reason foryour 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 leallet for complete directions on howr to use.

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

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 abowe 120°F (49°C].

Section 50565-1 (50565-1)

If 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 ofthe 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 ofthe 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 and/or patchy.

You do not knoww the reason foryour 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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