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

Purpose

Hair regrowth treatment

Description

Minoxidil 5% w/v


Medication Information

Warnings

For external use only.

Purpose

Hair regrowth treatment

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.

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).

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.

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.

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.

Active Ingredient(s)

Minoxidil 5% w/v

Package Label Principal Display Panel


Structured Label Content

Warnings

For external use only.

Purpose

Hair regrowth treatment

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.

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).

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.

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.

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.

Active Ingredient(s)

Minoxidil 5% w/v

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


Advanced Ingredient Data


Raw Label Data

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