SPL v1
SPL
SPL Set ID 16454f24-8333-4b6f-e063-6294a90a1c49
Route
TOPICAL
Published
Effective Date 2024-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 mg)
Inactive Ingredients
Glycerin Biotin Niacinamide Caffeine Water Alcohol Propylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-04-17

Description

Minoxidil 5%

Purpose

Hair regrowth treatment for men.


Medication Information

Purpose

Hair regrowth treatment for men.

Description

Minoxidil 5%

Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton.

Section 50565-1

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

●Chest pain, rapid heartbeat, faintness or dizziness occurs.

●Sudden, unexplained weight gain occurs.

●Your hands or feet swell.

●Scalp iritation or redness occurs.

●Unwanted facial hair growth occurs.

●You do not see hair regrowth in 4 months.

Section 50567-7

●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.

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Directions

●Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area.

●Using more or more often will not improve results.

●Continuous use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

Do Not Use

●You are a woman.

●Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the

scalp. Minoxidil topical solution 5% 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, iritated or painful.

●You use other medicines on the scalp.

Other Information

1.See hair loss pictures on side of this carton.

2.Before use, read all information on carton and enclosed leaflet.

3.Keep the carton. It contains important information.

4.Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil

topical solution 5% for men.

5.In clinical studies with mostly white men aged between 18-49 years with moderate degrees of hair loss, monoxidil topical

solution 5% for men provided more hair regrowth than minoxidil topical solution 2%,

6.Store at 20° to 259C (68° to 77°F). Keep tightly closed.

Active Ingredient(s)

Minoxidil 5%

Inactive Ingredients

Water, Alcohol, Propylene Glycol, Glycerol, Biotin, Caffeine, Niacinamide

Package Label Principal Display Panel


Structured Label Content

Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton.

Section 50565-1 (50565-1)

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

●Chest pain, rapid heartbeat, faintness or dizziness occurs.

●Sudden, unexplained weight gain occurs.

●Your hands or feet swell.

●Scalp iritation or redness occurs.

●Unwanted facial hair growth occurs.

●You do not see hair regrowth in 4 months.

Section 50567-7 (50567-7)

●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.

Purpose

Hair regrowth treatment for men.

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Directions

●Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area.

●Using more or more often will not improve results.

●Continuous use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

Do Not Use (Do not use)

●You are a woman.

●Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the

scalp. Minoxidil topical solution 5% 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, iritated or painful.

●You use other medicines on the scalp.

Other Information (Other information)

1.See hair loss pictures on side of this carton.

2.Before use, read all information on carton and enclosed leaflet.

3.Keep the carton. It contains important information.

4.Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil

topical solution 5% for men.

5.In clinical studies with mostly white men aged between 18-49 years with moderate degrees of hair loss, monoxidil topical

solution 5% for men provided more hair regrowth than minoxidil topical solution 2%,

6.Store at 20° to 259C (68° to 77°F). Keep tightly closed.

Active Ingredient(s)

Minoxidil 5%

Inactive Ingredients (Inactive ingredients)

Water, Alcohol, Propylene Glycol, Glycerol, Biotin, Caffeine, Niacinamide

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)