Minoxidil Topical Solution For Men

Minoxidil Topical Solution For Men
SPL v5
SPL
SPL Set ID a568aba1-1016-4380-e053-2a95a90a396d
Route
TOPICAL
Published
Effective Date 2021-11-30
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
ANDA Active Since 2020-05-08

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Indications and Usage

1 Bottle Carton

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

3 Bottle Carton

Use to regrow hair on the scalp

Dosage and Administration

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
Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • chest pain, rapid heartbeat, faintness, or dizziness occurs
  • sudden, unexplained weight gain occurs
  • your hands or feet swell
  • scalp irritation or redness occurs
  • unwanted facial hair growth occurs
  • you do not see hair regrowth in 4 months
Section 50567-7

When using this product

  • 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.
Section 50569-3

Ask a doctor before use if you have heart disease

Section 50570-1

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, irritated, or painful
  • you use other medicines on the scalp
Section 51727-6

Inactive ingredients Alcohol, propylene glycol, purified water

Section 53413-1

Questions? 1-424-347-6299 between 9:30 am and 9:00 pm EST, Monday–Friday.

Section 53414-9

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

Section 55105-1

1 Bottle Carton

Purpose

Hair regrowth treatment for men

3 Bottle Carton

Purpose

Hair regrowth treatment

Section 55106-9

1 Bottle Carton

Active ingredient

Minoxidil, USP 5% w/v

3 Bottle Carton

Active ingredient

Minoxidil 5% w/v

Section 60561-8

Other information

  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed leaflet
  • keep the carton. 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 to 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 controlled room temperature 20° to 25°C (68° to 77°F)
Three Bottle Package

NDC 72484-095-06

Men's Extra Strength

HAIR REGROWTH TREATMENT

roman

MINOXIDIL TOPICAL SOLUTION USP 5%

Reactivates hair follicles to stimulate regrowth

Clinically proven to help regrow hair

NOT FOR USE BY WOMEN

Unscented Topical Solution

Three month supply

Three 60 mL (2 fl oz) bottles

Single Bottle Package

NDC 72484-095-03

Men's Extra Strength

HAIR REGROWTH TREATMENT

roman MINOXIDIL TOPICAL SOLUTION USP 5%

Reactivates hair follicles to stimulate regrowth

Clinically proven to help regrow hair

NOT FOR USE BY WOMEN

Unscented Topical Solution

One month supply

One 60 mL (2 fl oz) Bottle


Structured Label Content

Indications and Usage (34067-9)

1 Bottle Carton

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

3 Bottle Carton

Use to regrow hair on the scalp

Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • chest pain, rapid heartbeat, faintness, or dizziness occurs
  • sudden, unexplained weight gain occurs
  • your hands or feet swell
  • scalp irritation or redness occurs
  • unwanted facial hair growth occurs
  • you do not see hair regrowth in 4 months
Section 50567-7 (50567-7)

When using this product

  • 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.
Section 50569-3 (50569-3)

Ask a doctor before use if you have heart disease

Section 50570-1 (50570-1)

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, irritated, or painful
  • you use other medicines on the scalp
Section 51727-6 (51727-6)

Inactive ingredients Alcohol, propylene glycol, purified water

Section 53413-1 (53413-1)

Questions? 1-424-347-6299 between 9:30 am and 9:00 pm EST, Monday–Friday.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

1 Bottle Carton

Purpose

Hair regrowth treatment for men

3 Bottle Carton

Purpose

Hair regrowth treatment

Section 55106-9 (55106-9)

1 Bottle Carton

Active ingredient

Minoxidil, USP 5% w/v

3 Bottle Carton

Active ingredient

Minoxidil 5% w/v

Section 60561-8 (60561-8)

Other information

  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed leaflet
  • keep the carton. 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 to 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 controlled room temperature 20° to 25°C (68° to 77°F)
Three Bottle Package (Three bottle package)

NDC 72484-095-06

Men's Extra Strength

HAIR REGROWTH TREATMENT

roman

MINOXIDIL TOPICAL SOLUTION USP 5%

Reactivates hair follicles to stimulate regrowth

Clinically proven to help regrow hair

NOT FOR USE BY WOMEN

Unscented Topical Solution

Three month supply

Three 60 mL (2 fl oz) bottles

Single Bottle Package

NDC 72484-095-03

Men's Extra Strength

HAIR REGROWTH TREATMENT

roman MINOXIDIL TOPICAL SOLUTION USP 5%

Reactivates hair follicles to stimulate regrowth

Clinically proven to help regrow hair

NOT FOR USE BY WOMEN

Unscented Topical Solution

One month supply

One 60 mL (2 fl oz) Bottle


Advanced Ingredient Data


Raw Label Data

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