76986-008

76986-008
SPL v1
SPL
SPL Set ID 3abe6f17-17ed-e25c-e063-6294a90a4d4d
Route
TOPICAL
Published
Effective Date 2025-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Hydrolyzed Sericin (enzymatic; 20000 Mw) Rosmarinus Officinalis Flower Platycladus Orientalis Leaf Alcohol Propylene Glycol Polysorbate 20 Water Dimethyl Isosorbide Hydroxyacetophenone Menthol Ethylhexylglycerin Acetyl Tetrapeptide-2 Biotin Glyceryl Caprylate Panax Ginseng Root 1,2-hexanediol Caffeine

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-07-25

Description

MINOXIDIL (5%)

Purpose

Hair regrowth treatment


Medication Information

Purpose

Hair regrowth treatment

Description

MINOXIDIL (5%)

Use

To regrow hair on the top of the scalp .

Stop Use

Ask a doctor before use if you have HEART DISEASE. Stop Using and ask a doctor if

· chest pain, rapid heart beat, faintness, or dizziness occurs.

· sudden, unexplained weight gain occurs.

· your hands or feet swell.

· scalp irritation or redness occurs.

· you get unwanted facial hair growth.

· you do not see hair regrowth in 4 months.

Warnings

· For external use only.

· Keep away from fire and flame.

Ask Doctor

Ask a doctor before use if you have HEART DISEASE. Stop Using and ask a doctor if

· chest pain, rapid heart beat, faintness, or dizziness occurs.

· sudden, unexplained weight gain occurs.

· your hands or feet swell.

· scalp irritation or redness occurs.

· you get unwanted facial hair growth.

· you do not see hair regrowth in 4 months.

Directions

Directions

.Wash the scalp before use .

.Apply 2-3 pumps once daily to the affected scalp, then gently massage it in. For best results, leave the product on for at least 4 hours before washing hair .

Do Not Use

Do not use if:

·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.

·the scalp is red, inflamed, infected, irritated, or painful.

·you are using other medicines on your scalp.

When Using

When Using this product:

■ 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.

■ lt takes time to regrow hair.

You may need to use this product once a day for at least 4 months before you see results.

Active Ingredient

MINOXIDIL (5%)

Other Information

Other information

· If you are using other drugs, please consult your physician or pharmacist before using this product.

· Store in a dry place at 20~25°C (68~77°F).

Inactive Ingredients

PROPYLENE GLYCOL

WATER

Polysorbate 20

POLYSORBATE 20

DIMETHYL ISOSORBIDE

HYDROLYZED RHODOPHYCEAE EXTRACT

1,2-Hexanediol

Biotin

Caffeine

Rosmarinus Officinalis (Rosemary) Extract

Panax Ginseng Root Extract

Alcohol

Platycladus Orientalis Leaf Extract

Glyceryl Caprylate

Hydroxyacetophenone

Ethylhexylglycerin

Mentholum(Menthol)

Acetyl Tetrapeptide-2

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of Children.

In case of accidental ingestion, get medical help or contact a poison control center immediately.


Structured Label Content

Use

To regrow hair on the top of the scalp .

Purpose

Hair regrowth treatment

Stop Use

Ask a doctor before use if you have HEART DISEASE. Stop Using and ask a doctor if

· chest pain, rapid heart beat, faintness, or dizziness occurs.

· sudden, unexplained weight gain occurs.

· your hands or feet swell.

· scalp irritation or redness occurs.

· you get unwanted facial hair growth.

· you do not see hair regrowth in 4 months.

Warnings

· For external use only.

· Keep away from fire and flame.

Ask Doctor

Ask a doctor before use if you have HEART DISEASE. Stop Using and ask a doctor if

· chest pain, rapid heart beat, faintness, or dizziness occurs.

· sudden, unexplained weight gain occurs.

· your hands or feet swell.

· scalp irritation or redness occurs.

· you get unwanted facial hair growth.

· you do not see hair regrowth in 4 months.

Directions

Directions

.Wash the scalp before use .

.Apply 2-3 pumps once daily to the affected scalp, then gently massage it in. For best results, leave the product on for at least 4 hours before washing hair .

Do Not Use (Do not use)

Do not use if:

·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.

·the scalp is red, inflamed, infected, irritated, or painful.

·you are using other medicines on your scalp.

When Using

When Using this product:

■ 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.

■ lt takes time to regrow hair.

You may need to use this product once a day for at least 4 months before you see results.

Active Ingredient

MINOXIDIL (5%)

Other Information (Other information)

Other information

· If you are using other drugs, please consult your physician or pharmacist before using this product.

· Store in a dry place at 20~25°C (68~77°F).

Inactive Ingredients (Inactive ingredients)

PROPYLENE GLYCOL

WATER

Polysorbate 20

POLYSORBATE 20

DIMETHYL ISOSORBIDE

HYDROLYZED RHODOPHYCEAE EXTRACT

1,2-Hexanediol

Biotin

Caffeine

Rosmarinus Officinalis (Rosemary) Extract

Panax Ginseng Root Extract

Alcohol

Platycladus Orientalis Leaf Extract

Glyceryl Caprylate

Hydroxyacetophenone

Ethylhexylglycerin

Mentholum(Menthol)

Acetyl Tetrapeptide-2

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep out of reach of Children.

In case of accidental ingestion, get medical help or contact a poison control center immediately.


Advanced Ingredient Data


Raw Label Data

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