SPL v4
SPL
SPL Set ID d158d3af-6850-48c0-8355-9df0637684cc
Route
TOPICAL
Published
Effective Date 2014-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (3 g)
Inactive Ingredients
Water Propylene Glycol Alcohol

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
ANDA Active Since 2014-07-30

Description

Minoxidil 5% w/v

Purpose

Hair Regrowth Treatment For Men


Medication Information

Purpose

Hair Regrowth Treatment For Men

Description

Minoxidil 5% w/v

Use

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

Section 51945-4

Warnings

For external use only. Flammable: Keep away from fire or flame.

Ask Doctor

Ask a doctor before use if you have heart disease.

Directions

Apply one mL 2 times daily directly onto the scalp in the hair loss area.

Using more or more often will not improve results.

Continued use is necessary or hair loss will resume.

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 or children.

Your scalp is red, inflamed, infected, irritated, or painful.

You use other medicines on the scalp.

Other Information

See hair loss picture on the side of this carton.

Before use, read all information on carton and printed insert.

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%.

In clinical studies with mostly caucasian men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% for men provided more hair growth than Minoxidil Topical Solution 2%.

Active Ingredients

Minoxidil 5% w/v

Inactive Ingredients

Alcohol, Propylene Glycol, Purified water

Questions Or Comments?

1-800-237-7157

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. Results may occur at 2 months with twice daily 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 everyone.

Pregnancy Or Breast Feeding

​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 immediately. (1-800-222-1222)

Stop Use and Ask A Doctor If You Have

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.


Structured Label Content

Use

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

Section 51945-4 (51945-4)

Purpose

Hair Regrowth Treatment For Men

Warnings

For external use only. Flammable: Keep away from fire or flame.

Ask Doctor (ASK DOCTOR)

Ask a doctor before use if you have heart disease.

Directions

Apply one mL 2 times daily directly onto the scalp in the hair loss area.

Using more or more often will not improve results.

Continued use is necessary or hair loss will resume.

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 or children.

Your scalp is red, inflamed, infected, irritated, or painful.

You use other medicines on the scalp.

Other Information (Other information)

See hair loss picture on the side of this carton.

Before use, read all information on carton and printed insert.

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%.

In clinical studies with mostly caucasian men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% for men provided more hair growth than Minoxidil Topical Solution 2%.

Active Ingredients

Minoxidil 5% w/v

Inactive Ingredients

Alcohol, Propylene Glycol, Purified water

Questions Or Comments? (Questions or Comments?)

1-800-237-7157

When Using This Product (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. Results may occur at 2 months with twice daily 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 everyone.

Pregnancy Or Breast Feeding (Pregnancy or breast feeding)

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

Keep Out of Reach of Children (Keep out of reach of children)

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

Stop Use and Ask A Doctor If You Have (Stop use and ask a doctor if you have)

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.


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