SPL v1
SPL
SPL Set ID 092f7745-1603-2ef0-e063-6394a90ad962
Route
TOPICAL
Published
Effective Date 2023-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Biotin Propylene Glycol Dimethyl Isosorbide Acetic Acid Water Panthenol Polysorbate 20 Niacinamide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-11-02

Description

Minoxidil 5% w/w

Purpose

Hair regrowth treatment


Medication Information

Purpose

Hair regrowth treatment

Description

Minoxidil 5% w/w

Use

to regrow hair on the scalp

Stop Use

If scalp irritation or redness occurs. If you get unwanted facial hair growth. If you do not see hair regrowth in 4 months.If sudden, unexplained weight gain occurs.

Warnings

For external use only.

Ask Doctor

If you have chest pain, rapid heart beat, faintness,

or dizziness occurs.

Directions

. Apply 2-3 drops of serum directly to the

scalp in the area to be treated.

. Massage into the scalp with your fingers

then wash hands thoroughly.

- Using more hair regrowth serum or

using the serum more often will not

improve your results.

. Continued use is necessary to increase

and then maintain your hair regrowth.

. Discontinuing use may result in hair loss.

Do Not Use

You have no family history of hair loss. 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 it on babies and children.Scalp is red, inflamed, infected, irritated or painful.You use other medicines on the scalp.

When Using

Do not apply on other parts of the body. Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water. It takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results, The amount of hair regrowth is different for each person.The product will not work for everyone.

Active Ingredient

Minoxidil 5% w/w

Other Information

Before use, read all information on the carton.

Keep the carton. It contains important

information.

Store at controlled room temperature 20

to 25℃ (68 to 77°F)

Contents under pressure. Do not

puncture or incinerate the container. Do

not expose to heat or store at

temperature above 120°F(49℃)

Inactive Ingredients

Inactive ingredients

water, biotin, dimethyl isosorbide,

acetic acid, panthenol, propylene glycol,

niacinamide, polysorbate 20

Principal Display Panel

Keep Oot of Reach of Children

If swallowed, get medical help or contact

a poison control center right away.


Structured Label Content

Use

to regrow hair on the scalp

Purpose

Hair regrowth treatment

Stop Use

If scalp irritation or redness occurs. If you get unwanted facial hair growth. If you do not see hair regrowth in 4 months.If sudden, unexplained weight gain occurs.

Warnings

For external use only.

Ask Doctor

If you have chest pain, rapid heart beat, faintness,

or dizziness occurs.

Directions

. Apply 2-3 drops of serum directly to the

scalp in the area to be treated.

. Massage into the scalp with your fingers

then wash hands thoroughly.

- Using more hair regrowth serum or

using the serum more often will not

improve your results.

. Continued use is necessary to increase

and then maintain your hair regrowth.

. Discontinuing use may result in hair loss.

Do Not Use (Do not use)

You have no family history of hair loss. 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 it on babies and children.Scalp is red, inflamed, infected, irritated or painful.You use other medicines on the scalp.

When Using

Do not apply on other parts of the body. Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water. It takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results, The amount of hair regrowth is different for each person.The product will not work for everyone.

Active Ingredient

Minoxidil 5% w/w

Other Information (Other information)

Before use, read all information on the carton.

Keep the carton. It contains important

information.

Store at controlled room temperature 20

to 25℃ (68 to 77°F)

Contents under pressure. Do not

puncture or incinerate the container. Do

not expose to heat or store at

temperature above 120°F(49℃)

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

water, biotin, dimethyl isosorbide,

acetic acid, panthenol, propylene glycol,

niacinamide, polysorbate 20

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

If swallowed, get medical help or contact

a poison control center right away.


Advanced Ingredient Data


Raw Label Data

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