87112-001 5% Minoxidil Hair Growth Topical Solution

87112-001 5% Minoxidil Hair Growth Topical Solution
SPL v1
SPL
SPL Set ID 473c555b-de13-56d5-e063-6394a90a377f
Route
TOPICAL
Published
Effective Date 2025-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g) Biotin (0.5 g)
Inactive Ingredients
Water Castor Oil Dexpanthenol Glycerin Alcohol Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-31

Description

Minoxidil 5% Biotin 0.5%


Medication Information

Warnings and Precautions

Keep out of reach of children.

For external use only

Indications and Usage

Use to regrow hair and beard.

Dosage and Administration



1. After opening the cap, apply 1 ml by pressing and dotting onto the scalp area to be treated.

2. Gently massage the scalp or sparse hair area until fully absorbed.

3. Use twice daily.

4. Continuous use is necessary to increase and maintain har regrowth. Stopping use may lead to hair loss

Description

Minoxidil 5% Biotin 0.5%

Section 50565-1

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

(1-800-222-1222)right away.

Section 50566-9



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

Sudden, unexplained weight gain occurs.

lf unwanted facial hair growth occurs

lf you do not see hair regrowth in 6 months.

Section 50567-7



Avold contact with the eves. in case of accidental contact, rinse eves 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 3 months with twice a day usage. For some men, you may need to use this product for at least 6 months before you see results. The amount of hair regrowth is diferent for each person.

Avoid contact with eyes. in case of accidental contact, rinse eyes with a large amount of cool tap water.

Section 50570-1

Your hair loss is sudden and/or patchy.

Your hair loss is associated with childbirth.

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

Butylene Glycol

Glycerin

Alcohol

Castor oil

Dexpanthenol

Water

Section 51945-4

Section 55105-1

Hair Regrowth Treatment

Section 55106-9

Minoxidil 5%

Biotin 0.5%


Structured Label Content

Indications and Usage (34067-9)

Use to regrow hair and beard.

Dosage and Administration (34068-7)



1. After opening the cap, apply 1 ml by pressing and dotting onto the scalp area to be treated.

2. Gently massage the scalp or sparse hair area until fully absorbed.

3. Use twice daily.

4. Continuous use is necessary to increase and maintain har regrowth. Stopping use may lead to hair loss

Warnings and Precautions (34071-1)

Keep out of reach of children.

For external use only

Section 50565-1 (50565-1)

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

(1-800-222-1222)right away.

Section 50566-9 (50566-9)



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

Sudden, unexplained weight gain occurs.

lf unwanted facial hair growth occurs

lf you do not see hair regrowth in 6 months.

Section 50567-7 (50567-7)



Avold contact with the eves. in case of accidental contact, rinse eves 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 3 months with twice a day usage. For some men, you may need to use this product for at least 6 months before you see results. The amount of hair regrowth is diferent for each person.

Avoid contact with eyes. in case of accidental contact, rinse eyes with a large amount of cool tap water.

Section 50570-1 (50570-1)

Your hair loss is sudden and/or patchy.

Your hair loss is associated with childbirth.

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)

Butylene Glycol

Glycerin

Alcohol

Castor oil

Dexpanthenol

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair Regrowth Treatment

Section 55106-9 (55106-9)

Minoxidil 5%

Biotin 0.5%


Advanced Ingredient Data


Raw Label Data

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