84148-016

84148-016
SPL v1
SPL
SPL Set ID 452c3d6b-af16-3d05-e063-6294a90a16f8
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
Glycerin Cetearyl Alcohol Simmondsia Chinensis (jojoba) Seed Oil Trehalose Aloe Vera Leaf Oil Panthenol Cetearyl Olivate Sorbitan Olivate Biotin Caffeine Alpha-tocopherol Acetate Rosmarinus Officinalis (rosemary) Leaf Oil Phenoxyethanol Sodium Hydroxide Ethylhexylglycerin Water

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

Use(s) to regrow hair

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 on other parts of the body.

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

Warnings

For external use only.

Directions

Apply right amount of hair growth cream on the hair loss

area, gently massage the scalp with your fingers until the

product is fully absorbed.

Do Not Use

·Your hair loss is sudden, uncertain or patchy.

.You are pregnant or breastfeeding.

.You are under 18 years of age.

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

·You use other medicines on the scalp.

Other Information

Store it in a cool, dry environment, away from heat, moisture, and direct light.

Active Ingredient(s)

Minoxidil 5% w/v

Inactive Ingredients

Water, Glycerin, Cetearyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil,Trehalose, Aloe Barbadensis Leaf

Water, Panthenol, Ceteary| Olivate, Sorbitan Olivate,Biotin, Caffeine, Hydrolyzed Keratin, Tocophery| Acetate,

Rosmarinus Officinalis(Rosemary) Leaf Oil, Phenoxyethanol,Sodium Hydroxide, Ethylhexylglycerin.

Package Label Principal Display Panel


Structured Label Content

Use

Use(s) to regrow hair

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 on other parts of the body.

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

Purpose

Hair regrowth treatment

Warnings

For external use only.

Directions

Apply right amount of hair growth cream on the hair loss

area, gently massage the scalp with your fingers until the

product is fully absorbed.

Do Not Use (Do not use)

·Your hair loss is sudden, uncertain or patchy.

.You are pregnant or breastfeeding.

.You are under 18 years of age.

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

·You use other medicines on the scalp.

Other Information (Other information)

Store it in a cool, dry environment, away from heat, moisture, and direct light.

Active Ingredient(s)

Minoxidil 5% w/v

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Cetearyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil,Trehalose, Aloe Barbadensis Leaf

Water, Panthenol, Ceteary| Olivate, Sorbitan Olivate,Biotin, Caffeine, Hydrolyzed Keratin, Tocophery| Acetate,

Rosmarinus Officinalis(Rosemary) Leaf Oil, Phenoxyethanol,Sodium Hydroxide, Ethylhexylglycerin.

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


Advanced Ingredient Data


Raw Label Data

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