84148-017

84148-017
SPL v1
SPL
SPL Set ID 452c9ee5-2c9d-f78d-e063-6394a90a7feb
Route
CUTANEOUS
Published
Effective Date 2025-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Edetate Disodium Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Lauryl Glucoside Cocamide Mipa Glycerin Propylene Glycol Biotin Panthenol Rosmarinus Officinalis (rosemary) Leaf Powder Polyquaternium-10 (1000 Mpa.s At 2%) Peg-7 Glyceryl Cocoate Citric Acid Phenoxyethanol Ethylhexylglycerin Parfumidine Aqua

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-05

Description

Minoxidil 5% w/v

Purpose

Hair regrowth treatment


Medication Information

Purpose

Hair regrowth treatment

Description

Minoxidil 5% w/v

Use

To regrow hair on the scalp

Section 50565-1

Keep out of reach of children.

Section 50566-9

Discontinue use if redness or irritation occurs.

Section 50567-7

. Do not apply to other parts of the body.

. Some people may experience changes in hair color and/or texture.

.Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

.It takes time to regrow hair. Results may occur at 3 months.For

some people, you may need to use this product for at least 6

months before you see results.

Warnings

For external use only.

Directions

1. Thoroughly wet hair and scalp with warm water. Use every 1 to 3 days.

2. Apply a generous amount of shampoo to your hair.

3. Gently massage into a rich lather for 3-5 minutes. Spend extra time on areas of concern.

4. Rinse thoroughly with warm water.

Do Not Use

.Your hair loss is associated with childbirth.

.You have sudden or unexplained hair loss.

. You are under 18 years of age.

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

·You are using other topical medicines on your scalp.

Other Information

.Store at controlled room temperature20°C to 25°C (68F to 77°F).

. Contents under pressure. Do not puncture or incinerate the container.

. Do not expose to heat or store at temperatures above 49°C (120°F).

Active Ingredient(s)

Minoxidil 5% w/v

Inactive Ingredients

Aqua (Water), Sodium C14-16 Olefin Sulfonate,Cocamidopropyl Betaine, Lauryl Glucoside,CocamideMIPA, Glycerin, Propylene

Glycol, Biotin, Panthenol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Polyquaternium-10, PEG-7 Glyceryl Cocoate, Citric Acid,

Phenoxyethanol, Ethylhexylglycerin, Fragrance (Parfum), Disodium EDTA.

Package Label Principal Display Panel


Structured Label Content

Use

To regrow hair on the scalp

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Discontinue use if redness or irritation occurs.

Section 50567-7 (50567-7)

. Do not apply to other parts of the body.

. Some people may experience changes in hair color and/or texture.

.Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

.It takes time to regrow hair. Results may occur at 3 months.For

some people, you may need to use this product for at least 6

months before you see results.

Purpose

Hair regrowth treatment

Warnings

For external use only.

Directions

1. Thoroughly wet hair and scalp with warm water. Use every 1 to 3 days.

2. Apply a generous amount of shampoo to your hair.

3. Gently massage into a rich lather for 3-5 minutes. Spend extra time on areas of concern.

4. Rinse thoroughly with warm water.

Do Not Use (Do not use)

.Your hair loss is associated with childbirth.

.You have sudden or unexplained hair loss.

. You are under 18 years of age.

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

·You are using other topical medicines on your scalp.

Other Information (Other information)

.Store at controlled room temperature20°C to 25°C (68F to 77°F).

. Contents under pressure. Do not puncture or incinerate the container.

. Do not expose to heat or store at temperatures above 49°C (120°F).

Active Ingredient(s)

Minoxidil 5% w/v

Inactive Ingredients (Inactive ingredients)

Aqua (Water), Sodium C14-16 Olefin Sulfonate,Cocamidopropyl Betaine, Lauryl Glucoside,CocamideMIPA, Glycerin, Propylene

Glycol, Biotin, Panthenol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Polyquaternium-10, PEG-7 Glyceryl Cocoate, Citric Acid,

Phenoxyethanol, Ethylhexylglycerin, Fragrance (Parfum), Disodium EDTA.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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