85304-019 5% Minoxidil Hair Growth Foam

85304-019 5% Minoxidil Hair Growth Foam
SPL v1
SPL
SPL Set ID 3feb9ac0-2cd1-9db2-e063-6394a90acab9
Route
TOPICAL
Published
Effective Date 2025-09-29
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 Edetate Disodium Alcohol Cetyl Alcohol Polysorbate 60 Water Butane Stearyl Alcohol Isobutane Citric Acid Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-29

Description

Minoxidil 5% Biotin 0.5%


Medication Information

Warnings and Precautions



Flammable: keep away from fire or flame.

Keep out of reach of children.

For extemal 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 hair loss will begin again.

Description

Minoxidil 5% Biotin 0.5%

Section 50565-1

Keep out of reach of children. if swalowed, 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 oceurs.

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 large amounts of cool tap water.

Some people have experienced changes in hair color and/or texture.

It takes ime to regrow hair, results may occur at2 months with twice a day usage, for some people, you may need to use this product for at least 4 months before you see results.

The amount of hair regrowth is diferent for each person. This product wil not 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

cetyl alcohol

citric acid

glycerin

isobutane

lactic acid

polysorbate 60

purified water

SD alcohol 40-B

stearyl alcohol

butane

edetate disodium

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 hair loss will begin again.

Warnings and Precautions (34071-1)



Flammable: keep away from fire or flame.

Keep out of reach of children.

For extemal use only.

Section 50565-1 (50565-1)

Keep out of reach of children. if swalowed, 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 oceurs.

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 large amounts of cool tap water.

Some people have experienced changes in hair color and/or texture.

It takes ime to regrow hair, results may occur at2 months with twice a day usage, for some people, you may need to use this product for at least 4 months before you see results.

The amount of hair regrowth is diferent for each person. This product wil not 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)

cetyl alcohol

citric acid

glycerin

isobutane

lactic acid

polysorbate 60

purified water

SD alcohol 40-B

stearyl alcohol

butane

edetate disodium

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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