5% Minoxidil Hair Growth Foam With Biotin

5% Minoxidil Hair Growth Foam With Biotin
SPL v1
SPL
SPL Set ID 25afb31d-ac2d-758f-e063-6294a90ae686
Route
TOPICAL
Published
Effective Date 2024-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-31

Description

5% Minoxidil Hair Growth Foam with Biotin


Medication Information

Warnings and Precautions

Flammable: keep away from fire or flame.

Keep out of reach of children.

For external use only

Indications and Usage

Use to regrow hair of the scalp

Dosage and Administration

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 leaflet 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 hairloss will begin again.

Description

5% Minoxidil Hair Growth Foam with Biotin

Section 42229-5

5% Minoxidil Hair Growth Foam with Biotin

Section 44425-7

Before use, read all information on carton and enclosed leaflet.Store at controlled room temperature 20° to 25°℃ (68° to 77°F)Do not incinerate container. Do not expose to heat or store at temperatureabove 104°F(40°C)

Section 50565-1

Keep out of reach of children. lf swallowed, get medical help or contact

a Poison Control Center(1-800-222-1222)right away.

Section 50566-9

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 regrowth in 4 months,

Section 50567-7

Do not apply on other parts of the body.

Avoid contact with the eyes. In case of accidental contact, rinse eyes with largeamounts 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 davusage, for some people, you may need to use this product for at least 4months before you see results.

The amount of hair regrowth is different for each person. This product willnot work for all people.

Section 50570-1

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.

Section 51727-6

ALCOHOL

GLYCERIN

CETYL ALCOHOL

STEARYL ALCOHOL

POLYSORBATE 80

ANHYDROUS CITRIC ACID

LACTIC ACID

CASTOR OIL

EDETATE DISODIUM

ISOBUTANE

BUTANE

WATER

Section 51945-4

Section 55105-1

Hair regrowth treatment for men and women

Section 55106-9

Minoxidil 5%

Biotin 0.5%


Structured Label Content

Indications and Usage (34067-9)

Use to regrow hair of the scalp

Dosage and Administration (34068-7)

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 leaflet 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 hairloss will begin again.

Warnings and Precautions (34071-1)

Flammable: keep away from fire or flame.

Keep out of reach of children.

For external use only

Section 42229-5 (42229-5)

5% Minoxidil Hair Growth Foam with Biotin

Section 44425-7 (44425-7)

Before use, read all information on carton and enclosed leaflet.Store at controlled room temperature 20° to 25°℃ (68° to 77°F)Do not incinerate container. Do not expose to heat or store at temperatureabove 104°F(40°C)

Section 50565-1 (50565-1)

Keep out of reach of children. lf swallowed, get medical help or contact

a Poison Control Center(1-800-222-1222)right away.

Section 50566-9 (50566-9)

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 regrowth in 4 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, rinse eyes with largeamounts 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 davusage, for some people, you may need to use this product for at least 4months before you see results.

The amount of hair regrowth is different for each person. This product willnot work for all people.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

ALCOHOL

GLYCERIN

CETYL ALCOHOL

STEARYL ALCOHOL

POLYSORBATE 80

ANHYDROUS CITRIC ACID

LACTIC ACID

CASTOR OIL

EDETATE DISODIUM

ISOBUTANE

BUTANE

WATER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair regrowth treatment for men and women

Section 55106-9 (55106-9)

Minoxidil 5%

Biotin 0.5%


Advanced Ingredient Data


Raw Label Data

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