SPL v1
SPL
SPL Set ID 12fd18f0-859c-7b9a-e063-6394a90addbf
Route
TOPICAL
Published
Effective Date 2024-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (0.6 g)
Inactive Ingredients
Panax Ginseng Root Oil Argan Oil Hyaluronic Acid Biotin Phenoxyethanol Rosmarinus Officinalis Flowering Top Oil Vitamin D5 Zingiberensis Saponin I 1,2-butanediol Glycerin Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-03-06

Description

MINOXIDIL 5%

Purpose

Hair Growth


Medication Information

Purpose

Hair Growth

Description

MINOXIDIL 5%

Dosage

Apply 1 ML(few drops)directly onto scalp on the hair loss area.

Use fingertips to massage solution into skin/hair for 2-3 minutes or use a roller to roll 4-5 times.

Allow time for hair to fully absorb Growth Oil, don't apply anything to your hair for a few hours.

Section 51945-4

Storage

Store in a dark, cool place.

Store at controlled room temperature 59°F-77°F(15°C-25°C).

Keep out of direct sunlight.

Keep the cap on tightly when not in use.

Warnings

For external use only. For use by men only.

Flammable : Keep away from fire or flame.

Keep out of reach of children.

How to Use

Apply 1 ML(few drops)directly onto scalp on the hair loss area.

Use fingertips to massage solution into skin/hair for 2-3 minutes or use a roller to roll 4-5 times.

Allow time for hair to fully absorb Growth Oil, don't apply anything to your hair for a few hours.

Do Not Use If

your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline.

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.

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.

Ask a doctor before use if you have heart disease.

May be harmful if used when pregnant or breast-feeding.

Active Ingredient

MINOXIDIL 5%

Inactive Ingredient

WATER 81%

ZINGIBERENSIS SAPONIN I 0.6%

PANAX GINSENG ROOT OIL 0.6%

BIOTIN 1%

ROSMARINUS OFFICINALIS FLOWERING TOP OIL 0.5%

VITAMIN D5 0.1%

1.2-BUTANEDIOL 5%

ARGAN OIL 0.6%

GLYCERIN 5%

HYALURONIC ACID 0.1%

PHENOXYETHANOL 0.5%

When Using This Product

Do not apply on other parts of the body.

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 2 months with twice a day usage.

For some men, you may need to use this product for at least 4 months before you see results.

The amount of hair regrowth is different for each person.

This product will not work for all men.

Stop Use and Ask A Doctor If

Chest pain, rapid heartbeat, faintness, or dizziness occurs

Sudden, unexplained weight gain occurs

Your hands or feet swell

Scalp irritation or redness occurs

Unwanted facial hair growth occurs

You do not see hair regrowth in 4 months

Keep Out of Reach of Children

Flammable : Keep away from fire or flame.

Keep out of reach of children.


Structured Label Content

Dosage (DOSAGE)

Apply 1 ML(few drops)directly onto scalp on the hair loss area.

Use fingertips to massage solution into skin/hair for 2-3 minutes or use a roller to roll 4-5 times.

Allow time for hair to fully absorb Growth Oil, don't apply anything to your hair for a few hours.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Hair Growth

Storage (STORAGE)

Store in a dark, cool place.

Store at controlled room temperature 59°F-77°F(15°C-25°C).

Keep out of direct sunlight.

Keep the cap on tightly when not in use.

Warnings (WARNINGS)

For external use only. For use by men only.

Flammable : Keep away from fire or flame.

Keep out of reach of children.

How to Use (HOW TO USE)

Apply 1 ML(few drops)directly onto scalp on the hair loss area.

Use fingertips to massage solution into skin/hair for 2-3 minutes or use a roller to roll 4-5 times.

Allow time for hair to fully absorb Growth Oil, don't apply anything to your hair for a few hours.

Do Not Use If (DO NOT USE IF)

your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline.

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.

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.

Ask a doctor before use if you have heart disease.

May be harmful if used when pregnant or breast-feeding.

Active Ingredient (ACTIVE INGREDIENT)

MINOXIDIL 5%

Inactive Ingredient (INACTIVE INGREDIENT)

WATER 81%

ZINGIBERENSIS SAPONIN I 0.6%

PANAX GINSENG ROOT OIL 0.6%

BIOTIN 1%

ROSMARINUS OFFICINALIS FLOWERING TOP OIL 0.5%

VITAMIN D5 0.1%

1.2-BUTANEDIOL 5%

ARGAN OIL 0.6%

GLYCERIN 5%

HYALURONIC ACID 0.1%

PHENOXYETHANOL 0.5%

When Using This Product (WHEN USING THIS PRODUCT)

Do not apply on other parts of the body.

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 2 months with twice a day usage.

For some men, you may need to use this product for at least 4 months before you see results.

The amount of hair regrowth is different for each person.

This product will not work for all men.

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

Chest pain, rapid heartbeat, faintness, or dizziness occurs

Sudden, unexplained weight gain occurs

Your hands or feet swell

Scalp irritation or redness occurs

Unwanted facial hair growth occurs

You do not see hair regrowth in 4 months

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Flammable : Keep away from fire or flame.

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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