SPL v1
SPL
SPL Set ID 449fd486-69e2-2894-e063-6394a90a1421
Route
TOPICAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Propylene Glycol Potassium Sorbate Castor Oil Water Chamomile Cymbopogon Citratus Leaf Rosemary Biotin Lavender Oil Ginger

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-27

Description

Minoxidil 5% w/w

Purpose

Hair Regrowth


Medication Information

Purpose

Hair Regrowth

Description

Minoxidil 5% w/w

Use

Use to regrow hair of the scalp and beard growth for men and wemen

Section 51945-4

Warnings

Warnings

For external use only.

Keep out of reach of children.

Directions

Directions

Apply twice a day. Once in the morning and another time in the

evening before bed

Spray directly on top of the scalp in the area to be treated

Using more than directed or more often will not improve results

Continued use is necessary to lncrease and then malntain your

hair regrowth

When Using

When Using

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

Do Not Use If

Do not use if

You have no family history of hair loss.

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.

Active Ingredient

Minoxidil 5% w/w

Other Information

Other information

Before use, read all information on carton and enclosed leaflet.

Store at controlled room temperature 10° to 30°C (50° to 80°F).

Do not incinerate container. Do not expose to heat or store at temperature above 104°F (40°C).

Inactive Ingredients

Water, Propylene Glycol, Potassium Sorbate, Castor Oil, Lavender Oil, Cymbopogon Citratus Leaf, Chamomile, Biotin , Rosemary Oil, Ginger, Batana Oil

Stop Use and Ask A Doctor

Stop Use And Ask A Doctor

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

Sudden, unexplained weight gain occurs.

Scalp irritation or redness occurs.

Keep out of reach of children.

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

Keep Out of Reach of Children

Keep Out Of Reach Of Children


Structured Label Content

Use

Use to regrow hair of the scalp and beard growth for men and wemen

Section 51945-4 (51945-4)

Purpose

Hair Regrowth

Warnings

Warnings

For external use only.

Keep out of reach of children.

Directions

Directions

Apply twice a day. Once in the morning and another time in the

evening before bed

Spray directly on top of the scalp in the area to be treated

Using more than directed or more often will not improve results

Continued use is necessary to lncrease and then malntain your

hair regrowth

When Using

When Using

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

Do Not Use If (Do not use if)

Do not use if

You have no family history of hair loss.

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.

Active Ingredient (ACTIVE INGREDIENT)

Minoxidil 5% w/w

Other Information (Other information)

Other information

Before use, read all information on carton and enclosed leaflet.

Store at controlled room temperature 10° to 30°C (50° to 80°F).

Do not incinerate container. Do not expose to heat or store at temperature above 104°F (40°C).

Inactive Ingredients (Inactive ingredients)

Water, Propylene Glycol, Potassium Sorbate, Castor Oil, Lavender Oil, Cymbopogon Citratus Leaf, Chamomile, Biotin , Rosemary Oil, Ginger, Batana Oil

Stop Use and Ask A Doctor (Stop Use And Ask A Doctor)

Stop Use And Ask A Doctor

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

Sudden, unexplained weight gain occurs.

Scalp irritation or redness occurs.

Keep out of reach of children.

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

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep Out Of Reach Of Children


Advanced Ingredient Data


Raw Label Data

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