84232-001

84232-001
SPL v3
SPL
SPL Set ID 15ac989a-6602-d6ec-e063-6294a90a8a48
Route
TOPICAL
Published
Effective Date 2024-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5.6 mL)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-04-09

Description

Minoxidil 5% w/v

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Minoxidil 5% w/v

Use

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use

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

●Sudden, unexplained weight gain occurs

●Your hands or feet swell

●Scalp rritation or redness ocurs

●Unwanted facial hair growth occurs

●You do not see hair growth in 4 months

Warnings

For external use only. For use by men only.FI ammable: 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 resufts.

●continued 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, 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 sol ution 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 sol lution 2%

●Store at 20° to 25*C (68° to 77*F). Keep tightly closed

Active Ingredient(s)

Minoxidil 5% w/v

When Using This Product.

●Do not apply on other parts of your body.

●Avoid contact with the eyes. In case 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 hai, 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,

Package Label Principal Display Panel


Structured Label Content

Use

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic, Hand Sanitizer

Stop Use (Stop use)

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

●Sudden, unexplained weight gain occurs

●Your hands or feet swell

●Scalp rritation or redness ocurs

●Unwanted facial hair growth occurs

●You do not see hair growth in 4 months

Warnings

For external use only. For use by men only.FI ammable: 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 resufts.

●continued 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, 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 sol ution 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 sol lution 2%

●Store at 20° to 25*C (68° to 77*F). Keep tightly closed

Active Ingredient(s)

Minoxidil 5% w/v

When Using This Product. (When using this product.)

●Do not apply on other parts of your body.

●Avoid contact with the eyes. In case 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 hai, 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,

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


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