83887-003

83887-003
SPL v1
SPL
SPL Set ID 0e6b7931-6c9f-9057-e063-6294a90ad725
Route
TOPICAL
Published
Effective Date 2024-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Propanediol Phenoxyethanol Hyaluronic Acid Pantothenic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-07

Description

Minoxidil 5%

Purpose

Hair regrowth treatment


Medication Information

Purpose

Hair regrowth treatment

Description

Minoxidil 5%

Use

1.Do not apply on other parts of the body.

2.Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.

3.Some people have experienced changes in hair color and/or texture.

4.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.

5.The amount of hair regrowth is different for each person. This product will not work for all people.

Stop Use

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

2.Sudden, unexplained weight gain occurs.

3.Your hands or feet swell.

4.Scalp irritation or redness occurs.

5.Unwanted facial hair growth occurs.

6.You do not see hair regrowth in 4 months.

Warnings

For external use only.

Flammable: Keep away from fire or flame.

Ask Doctor

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 at 1-800-222-1222.

Directions

1.Apply one ML with a dropper two times a day directly onto the scalp in the hair loss area.

2.Using more or more often will not improve results.

3.Continued use is necessary to increase and maintain hair regrowth; otherwise, hair loss will likely resume.

Do Not Use

1.Your hair loss is on the front of the scalp.

2.You have no family history of hair loss.

3. hair loss is sudden and/or patchy.

4.You do not know the reason for your hair loss.

5.You are under 18 years of age. Do not use on babies and children.

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

7.You use other medicines on the scalp.

When Using

1.Do not apply on other parts of the body.

2.Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.

3.Some people have experienced changes in hair color and/or texture.

4.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.

5.The amount of hair regrowth is different for each person. This product will not work for all people.

Active Ingredient

Minoxidil 5%

Other Information

1.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.

2.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%.

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

Inactive Ingredients

Purified Water,Propanediol,Phenoxyethanol,Hyaluronic Acid,Vitamin B5

Principal Display Panel

Keep Oot of Reach of Children

Keep Oot Of Reach Of Children


Structured Label Content

Use

1.Do not apply on other parts of the body.

2.Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.

3.Some people have experienced changes in hair color and/or texture.

4.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.

5.The amount of hair regrowth is different for each person. This product will not work for all people.

Purpose

Hair regrowth treatment

Stop Use

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

2.Sudden, unexplained weight gain occurs.

3.Your hands or feet swell.

4.Scalp irritation or redness occurs.

5.Unwanted facial hair growth occurs.

6.You do not see hair regrowth in 4 months.

Warnings

For external use only.

Flammable: Keep away from fire or flame.

Ask Doctor

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 at 1-800-222-1222.

Directions

1.Apply one ML with a dropper two times a day directly onto the scalp in the hair loss area.

2.Using more or more often will not improve results.

3.Continued use is necessary to increase and maintain hair regrowth; otherwise, hair loss will likely resume.

Do Not Use (Do not use)

1.Your hair loss is on the front of the scalp.

2.You have no family history of hair loss.

3. hair loss is sudden and/or patchy.

4.You do not know the reason for your hair loss.

5.You are under 18 years of age. Do not use on babies and children.

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

7.You use other medicines on the scalp.

When Using

1.Do not apply on other parts of the body.

2.Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.

3.Some people have experienced changes in hair color and/or texture.

4.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.

5.The amount of hair regrowth is different for each person. This product will not work for all people.

Active Ingredient

Minoxidil 5%

Other Information (Other information)

1.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.

2.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%.

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

Inactive Ingredients (Inactive ingredients)

Purified Water,Propanediol,Phenoxyethanol,Hyaluronic Acid,Vitamin B5

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep Oot Of Reach Of Children


Advanced Ingredient Data


Raw Label Data

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