SPL v1
SPL
SPL Set ID 2d34dc32-47d8-590d-e063-6294a90a2f2d
Route
EXTRACORPOREAL
Published
Effective Date 2024-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g) Biotin (1 mL)
Inactive Ingredients
Stearyl Alcohol Anhydrous Citric Acid Lactic Acid Glycerin Water Castor Oil Polysorbate 80 Cetyl Alcohol

Identifiers & Packaging

Pill Appearance
Shape: oval
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-01

Description

For external use only. Extremely Flammable: Avoid fire, flame, or smoking during andimmediately following application.


Medication Information

Warnings and Precautions

For external use 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 leaflet for complete directions on how to use.

Apply half a capful twice daily directly to the scalp in the hair loss area

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

For external use only. Extremely Flammable: Avoid fire, flame, or smoking during andimmediately following application.

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 attemperature abowe 120°F (49°C).

Section 50565-1

swallowed, get medical help or contact a Poison Control Center rightaway.(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 use more than directed.

Do not apply on other parts of the body.

Avoid contact with the eyes, In case of accidental contact, rinse eyeswith large amounts of cool tap water.

For some women, you may need to use this product once a day forat least 6 months before you see results.

The amount of hair regrowth is different for each person. Thisproduct will not work for all women,

Section 50570-1

your degree of hair loss is different than that shown on side of thiscarton because this product may not work for you.

You have no family history of hair loss.

Your hair loss is sudden and/or patchy.

You do not know the reason for your hair loss.

Your hair loss is associated with childbirth.

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 5%

Section 69761-5

For external use only.

Extremely Flammable: Avoid fire, flame, or smoking during andimmediately following application.


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 leaflet for complete directions on how to use.

Apply half a capful twice daily directly to the scalp in the hair loss area

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. Extremely Flammable: Avoid fire, flame, or smoking during andimmediately following application.

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 attemperature abowe 120°F (49°C).

Section 50565-1 (50565-1)

swallowed, get medical help or contact a Poison Control Center rightaway.(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 use more than directed.

Do not apply on other parts of the body.

Avoid contact with the eyes, In case of accidental contact, rinse eyeswith large amounts of cool tap water.

For some women, you may need to use this product once a day forat least 6 months before you see results.

The amount of hair regrowth is different for each person. Thisproduct will not work for all women,

Section 50570-1 (50570-1)

your degree of hair loss is different than that shown on side of thiscarton because this product may not work for you.

You have no family history of hair loss.

Your hair loss is sudden and/or patchy.

You do not know the reason for your hair loss.

Your hair loss is associated with childbirth.

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 5%

Section 69761-5 (69761-5)

For external use only.

Extremely Flammable: Avoid fire, flame, or smoking during andimmediately following application.


Advanced Ingredient Data


Raw Label Data

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