SPL v1
SPL
SPL Set ID 08c6d31f-f685-63e9-e063-6394a90a04b4
Route
TOPICAL
Published
Effective Date 2023-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Water Alcohol Glycerin

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-10-28

Description

Minoxidil 5%


Medication Information

Warnings and Precautions

Warnings

-For external use only.

-Keep away from fire and flame.

-Avoid contact with eyes.

Indications and Usage

Use to regrow hair on the top of the scalp.

Dosage and Administration

Directions

-Apply 1ml (7 Sprays) twice a day.

Once in the morning and another time in the evening before bed.

-Spray directly on top of the scalp in the area to be treated.

-Using more than directed or more often will not improve results.

-Continued use is necessary to increase and then maintain your hair regrowth.

-Discontinuing use may result in hair loss.

Description

Minoxidil 5%

Section 50565-1

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9

Stop use and ask 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

-May be harmful when pregnant or breast-feeding

Section 50567-7

When using

-Do not apply on other parts of the body.

-void 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 a least 4 months before you see results, The amount of hair regrowth is different for each person

Section 50569-3

Ask a Doctor before use if you

have Heart disease.

Section 50570-1

Do not use

-You have no family history of hair loss,hair loss is sudden and/orpatchy.

-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.

-Your scalp is red,inflamed, infect-edirritated,or painful.

-You use other medicines on the scalp.

Section 51727-6

Inactive ingredients

Propylene Glycol, Ethyl Alcohol, Aqua.

Section 51945-4

Section 55105-1

Hair Regrowth Treatment

Section 55106-9

Minoxidil 5%

Section 60561-8

Other information

-Before use, read all information on the carton.

-Store at controlled room temperature 20 to 25 ℃ (68 to 77°F)


Structured Label Content

Indications and Usage (34067-9)

Use to regrow hair on the top of the scalp.

Dosage and Administration (34068-7)

Directions

-Apply 1ml (7 Sprays) twice a day.

Once in the morning and another time in the evening before bed.

-Spray directly on top of the scalp in the area to be treated.

-Using more than directed or more often will not improve results.

-Continued use is necessary to increase and then maintain your hair regrowth.

-Discontinuing use may result in hair loss.

Warnings and Precautions (34071-1)

Warnings

-For external use only.

-Keep away from fire and flame.

-Avoid contact with eyes.

Section 50565-1 (50565-1)

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9 (50566-9)

Stop use and ask 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

-May be harmful when pregnant or breast-feeding

Section 50567-7 (50567-7)

When using

-Do not apply on other parts of the body.

-void 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 a least 4 months before you see results, The amount of hair regrowth is different for each person

Section 50569-3 (50569-3)

Ask a Doctor before use if you

have Heart disease.

Section 50570-1 (50570-1)

Do not use

-You have no family history of hair loss,hair loss is sudden and/orpatchy.

-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.

-Your scalp is red,inflamed, infect-edirritated,or painful.

-You use other medicines on the scalp.

Section 51727-6 (51727-6)

Inactive ingredients

Propylene Glycol, Ethyl Alcohol, Aqua.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair Regrowth Treatment

Section 55106-9 (55106-9)

Minoxidil 5%

Section 60561-8 (60561-8)

Other information

-Before use, read all information on the carton.

-Store at controlled room temperature 20 to 25 ℃ (68 to 77°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)