84558-011

84558-011
SPL v1
SPL
SPL Set ID 3a7b25bc-0a8b-cb6d-e063-6294a90a2325
Route
TOPICAL
Published
Effective Date 2025-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Peg-40 Hydrogenated Castor Oil Glycine Water Propylene Glycol Glycerin Butanediol (mixed Isomers) Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-22

Description

Minoxidil 5%

Purpose

Hair regrowth treatment


Medication Information

Purpose

Hair regrowth

treatment

Description

Minoxidil 5%

Use

Apply 1 ml twice a day directly onto the scalp in the hair loss area for men or women.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

right away

Section 50566-9

Chest pain, rapid heartbeat, faintness, or dizziness occurs.

Sudden, unexpiained weight gain occurs.

Your hands or feet swell.

Scalp rrritation or redness occurs.

Unwanted facial hair growth occurs.

You do not see hair regrowth in 4 months.

Section 50567-7

Do nott apply on other parts of the body. Avoid contact with the eyes, in case of accidental contact, rinse eyes with a large

amount 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 4 months with continuous usage. The amount of hair regrowth is different

for each person. This product will not work for everyone.





Warnings

For external use only

Flammable: keep away from fire or flame

Directions

Apply 1 ml twice a day directly onto the scalp in the hair loss area for men or women.

Using more or more often will not improve results loss will begain again.

Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

Do Not Use

you have family history of hair loss.

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 redinfamed, infected, imitated or painful.

you use other medicines on the scalp.

Other Information

Before use, read all information on carton. Keep the carton, it contains important iformation.

Store at 20-25°C(68-77'F). Keep tightly closed.

Active Ingredient(s)

Minoxidil 5%

Inactive Ingredients

WATER, PROPYL .ENE GLYCOL, GLYCERIN, BUTANEDIOL, GLYCINE, XANTHAN GUM,

PEG- 40H HYDROGENATED CASTOR OIL

Package Label Principal Display Panel


Structured Label Content

Use

Apply 1 ml twice a day directly onto the scalp in the hair loss area for men or women.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

right away

Section 50566-9 (50566-9)

Chest pain, rapid heartbeat, faintness, or dizziness occurs.

Sudden, unexpiained weight gain occurs.

Your hands or feet swell.

Scalp rrritation or redness occurs.

Unwanted facial hair growth occurs.

You do not see hair regrowth in 4 months.

Section 50567-7 (50567-7)

Do nott apply on other parts of the body. Avoid contact with the eyes, in case of accidental contact, rinse eyes with a large

amount 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 4 months with continuous usage. The amount of hair regrowth is different

for each person. This product will not work for everyone.





Purpose

Hair regrowth

treatment

Warnings

For external use only

Flammable: keep away from fire or flame

Directions

Apply 1 ml twice a day directly onto the scalp in the hair loss area for men or women.

Using more or more often will not improve results loss will begain again.

Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

Do Not Use (Do not use)

you have family history of hair loss.

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 redinfamed, infected, imitated or painful.

you use other medicines on the scalp.

Other Information (Other information)

Before use, read all information on carton. Keep the carton, it contains important iformation.

Store at 20-25°C(68-77'F). Keep tightly closed.

Active Ingredient(s)

Minoxidil 5%

Inactive Ingredients (Inactive ingredients)

WATER, PROPYL .ENE GLYCOL, GLYCERIN, BUTANEDIOL, GLYCINE, XANTHAN GUM,

PEG- 40H HYDROGENATED CASTOR OIL

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)