85304-016 5% Minoxidil Hair Growth Foam With Biotin

85304-016 5% Minoxidil Hair Growth Foam With Biotin
SPL v1
SPL
SPL Set ID 3e5595a6-b36e-2567-e063-6294a90a2078
Route
TOPICAL
Published
Effective Date 2025-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Biotin (0.5 g) Minoxidil (5 g)
Inactive Ingredients
Isobutane Polysorbate 60 Citric Acid Lactic Acid Cetyl Alcohol Glycerin Butane Edetate Disodium Water Stearyl Alcohol Alcohol

Identifiers & Packaging

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

Description

Minoxidil 5% Biotin 0.5%


Medication Information

Warnings and Precautions

Keep out of reach of children.

For external use only.

Indications and Usage

Use to regrow hair and beard.

Dosage and Administration



1.Make sure your hair and scalp are dry(no need to wash your hair before each use).

2.Apply 3-4 pumps of foam directly to the treated area of the scalp.

3.Gently massage into the scalp or thinning hair areas until absorbed.

4.Continued use is required to increase and maintain hair regrowth. Discontinuation may lead to hair loss

Description

Minoxidil 5% Biotin 0.5%

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.

If unwanted facial hair growth occurs .

If you do not see hair regrowth in 6 months

Section 50567-7



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 time to regrow hair. Results may occur at 3 months with twice a day usage. For some men, you may need to use this product for at least 6 months before you see results. The amount of hair regrowth is different for each person.

Avoid contact with eyes. in case of accidental contact, rinse eyes with a large amount of cool tap water.

Section 50570-1

Your hair loss is sudden and/or patchy.

Your hair loss is associated with childbirth.

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

Section 55106-9

Minoxidil 5%

Biotin 0.5%


Structured Label Content

Indications and Usage (34067-9)

Use to regrow hair and beard.

Dosage and Administration (34068-7)



1.Make sure your hair and scalp are dry(no need to wash your hair before each use).

2.Apply 3-4 pumps of foam directly to the treated area of the scalp.

3.Gently massage into the scalp or thinning hair areas until absorbed.

4.Continued use is required to increase and maintain hair regrowth. Discontinuation may lead to hair loss

Warnings and Precautions (34071-1)

Keep out of reach of children.

For external use only.

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.

If unwanted facial hair growth occurs .

If you do not see hair regrowth in 6 months

Section 50567-7 (50567-7)



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 time to regrow hair. Results may occur at 3 months with twice a day usage. For some men, you may need to use this product for at least 6 months before you see results. The amount of hair regrowth is different for each person.

Avoid contact with eyes. in case of accidental contact, rinse eyes with a large amount of cool tap water.

Section 50570-1 (50570-1)

Your hair loss is sudden and/or patchy.

Your hair loss is associated with childbirth.

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

Section 55106-9 (55106-9)

Minoxidil 5%

Biotin 0.5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)