Minoxidil 5%, Hair-regen Derma Roller Included, 60ml*6bottle

Minoxidil 5%, Hair-regen Derma Roller Included, 60ml*6bottle
SPL v1
SPL
SPL Set ID 4a161151-af5e-ea52-e063-6394a90ad97d
Route
TOPICAL
Published
Effective Date 2026-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2026-02-06

Description

Minoxidil 5% w/v

Purpose

Hair Regrowth Treatment


Medication Information

Purpose

Hair Regrowth Treatment

Description

Minoxidil 5% w/v

Use

to regrow hair on top of scalp (vertex only, see pictures on side of box)

Section 44425-7

Store at 20° to 25℃ (68° to 77℉). Keep cap tightly closed.

Section 50565-1

Do not use it on babies and children.

Section 50569-3

Ask your doctor before use if you have any symptoms and warning signs of heart disease.

Section 51945-4

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.
  • Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.
Do Not Use If...
  • 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, rritated, or painful.
  • You use other medicines on the scalp.
Other Information
  • See hair loss pictures on side of box.
  • Before use, read all information on box and enclosed instructions.
  • Keep the box, it contains important information.
  • 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.
  • In Clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
  • Store at 20° to 25℃ (68° to 77℉). Keep cap tightly closed.
Active Ingredients

Minoxidil 5% w/v

Inactive Ingredients

alcohol, propylene glycol, purified water

When Using This Product...
  • Do not apply on other parts of your body.
  • Avoid contact with the eyes. In case of accidental contact, rinse eyes with 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 on all men.
Stop Use and Ask Doctor If...
  • Chest pain, rapid heartbeat, faintness, or dizziness occurs
  • Sudden, unexplained weight gain occurs
  • Your hands or feet swell
  • Scalp rritation or redness occurs
  • Unwanted facial hair growth occurs
  • You do not see hair growth in 4 months

Structured Label Content

Use (USE)

to regrow hair on top of scalp (vertex only, see pictures on side of box)

Section 44425-7 (44425-7)

Store at 20° to 25℃ (68° to 77℉). Keep cap tightly closed.

Section 50565-1 (50565-1)

Do not use it on babies and children.

Section 50569-3 (50569-3)

Ask your doctor before use if you have any symptoms and warning signs of heart disease.

Section 51945-4 (51945-4)

Purpose

Hair Regrowth Treatment

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.
  • Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.
Do Not Use If... (Do not use if...)
  • 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, rritated, or painful.
  • You use other medicines on the scalp.
Other Information (Other information)
  • See hair loss pictures on side of box.
  • Before use, read all information on box and enclosed instructions.
  • Keep the box, it contains important information.
  • 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.
  • In Clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
  • Store at 20° to 25℃ (68° to 77℉). Keep cap tightly closed.
Active Ingredients

Minoxidil 5% w/v

Inactive Ingredients

alcohol, propylene glycol, purified water

When Using This Product... (When using this product...)
  • Do not apply on other parts of your body.
  • Avoid contact with the eyes. In case of accidental contact, rinse eyes with 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 on all men.
Stop Use and Ask Doctor If... (Stop use and ask doctor if...)
  • Chest pain, rapid heartbeat, faintness, or dizziness occurs
  • Sudden, unexplained weight gain occurs
  • Your hands or feet swell
  • Scalp rritation or redness occurs
  • Unwanted facial hair growth occurs
  • You do not see hair growth in 4 months

Advanced Ingredient Data


Raw Label Data

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