84095-005

84095-005
SPL v1
SPL
SPL Set ID 18a1ac86-9ee8-622a-e063-6294a90a1dc4
Route
TOPICAL
Published
Effective Date 2024-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-17

Description

Minoxidil 5%

Purpose

Hair regrowth treatment


Medication Information

Purpose

Hair regrowth treatment

Description

Minoxidil 5%

Use

Use to regrow hair on the top of the scalp (vertex only)

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

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

Directions

1.Twice a day, apply 1mL directly to 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 keep your hair regrowth or hair loss will begin again

Do Not Use

1.Your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.

2.You have no family history of hair loss

3.Your 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.lt 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.The duration of hair regrowth in men treated with continued use of minoxidil 5% topical solution has not exceeded 48 weeks

2.Store at 20° to 25C (68° to 77°F). Keep tightly closed.Place the product in a ventilated and dry place.

Inactive Ingredients

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

Principal Display Panel

Keep Oot of Reach of Children

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


Structured Label Content

Use

Use to regrow hair on the top of the scalp (vertex only)

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

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

Directions

1.Twice a day, apply 1mL directly to 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 keep your hair regrowth or hair loss will begin again

Do Not Use (Do not use)

1.Your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.

2.You have no family history of hair loss

3.Your 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.lt 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.The duration of hair regrowth in men treated with continued use of minoxidil 5% topical solution has not exceeded 48 weeks

2.Store at 20° to 25C (68° to 77°F). Keep tightly closed.Place the product in a ventilated and dry place.

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


Advanced Ingredient Data


Raw Label Data

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