SPL v1
SPL
SPL Set ID 08fa1a91-1e4b-7d99-e063-6294a90aa840
Route
TOPICAL
Published
Effective Date 2023-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2023-10-31

Description

5% Minoxidil


Medication Information

Warnings and Precautions

Warnings

For external use only

Flammable: keep away from fire or flame

Indications and Usage

Use to regrow hair on the vertex/crown scalp only.

Dosage and Administration

HOW TO USE

STEP 1

For scalp

Directly spray the scalp with four sprays from the crown, to the frontal region

STEP 2

Massage the scalp with your fingers to distribute the lotion evenly. Do it with some pressure to increase the blood flow for the scalp

Description

5% Minoxidil

Section 50565-1

Keep out of reach of children and pets.

If swallowed, get medical help or contact a poison control center right away.

Section 50566-9

Stop use and consult a doctor if you experience:

●Chest pain, rapid heartbeat, lightheadedness, or dizziness.

●Sudden, unexplained weight gain.

●Swelling of hands or feet.

●Scalp irritation or redness.

●Unwanted facial hair growth.

●No hair regrowth in 4 months.

Section 50567-7

When using this product:

● Do not apply to other parts of the body.

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

● Some people have experienced changes in hair color and texture.

● It takes time to regrow hair. Results may be seen after 2 months of twice-a-day application. For some people, you may need to use this product for at least 4 months before seeing results.

● The amount of hair regrowth is different for each individual. This product will not be effective for all people.

Section 50569-3

Consult a doctor before use if you have heart disease!

Section 51727-6

Inactive ingredients:

Water, Alcohol,Asian Ginseng,Ginger,Carthamus Tinctorius Whole ,Ligusticum Chuanxiong Root Extract,Glycyrrhiza Uralensis Whole,Arctium Lappa Whole,Angelica Sinensis Whole,Capsaicin , Vitamin H (Biotin) ,Collagen

Section 51945-4

Section 55105-1

Hair regrowth treatment

Section 55106-9

5% Minoxidil

Section 60561-8

Other information:

●Before use, read all information on the carton .

●Keep the carton, as it contains important information.

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

●May be harmful if used when pregnant or breastfeeding.


Structured Label Content

Indications and Usage (34067-9)

Use to regrow hair on the vertex/crown scalp only.

Dosage and Administration (34068-7)

HOW TO USE

STEP 1

For scalp

Directly spray the scalp with four sprays from the crown, to the frontal region

STEP 2

Massage the scalp with your fingers to distribute the lotion evenly. Do it with some pressure to increase the blood flow for the scalp

Warnings and Precautions (34071-1)

Warnings

For external use only

Flammable: keep away from fire or flame

Section 50565-1 (50565-1)

Keep out of reach of children and pets.

If swallowed, get medical help or contact a poison control center right away.

Section 50566-9 (50566-9)

Stop use and consult a doctor if you experience:

●Chest pain, rapid heartbeat, lightheadedness, or dizziness.

●Sudden, unexplained weight gain.

●Swelling of hands or feet.

●Scalp irritation or redness.

●Unwanted facial hair growth.

●No hair regrowth in 4 months.

Section 50567-7 (50567-7)

When using this product:

● Do not apply to other parts of the body.

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

● Some people have experienced changes in hair color and texture.

● It takes time to regrow hair. Results may be seen after 2 months of twice-a-day application. For some people, you may need to use this product for at least 4 months before seeing results.

● The amount of hair regrowth is different for each individual. This product will not be effective for all people.

Section 50569-3 (50569-3)

Consult a doctor before use if you have heart disease!

Section 51727-6 (51727-6)

Inactive ingredients:

Water, Alcohol,Asian Ginseng,Ginger,Carthamus Tinctorius Whole ,Ligusticum Chuanxiong Root Extract,Glycyrrhiza Uralensis Whole,Arctium Lappa Whole,Angelica Sinensis Whole,Capsaicin , Vitamin H (Biotin) ,Collagen

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair regrowth treatment

Section 55106-9 (55106-9)

5% Minoxidil

Section 60561-8 (60561-8)

Other information:

●Before use, read all information on the carton .

●Keep the carton, as it contains important information.

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

●May be harmful if used when pregnant or breastfeeding.


Advanced Ingredient Data


Raw Label Data

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