84148-013

84148-013
SPL v2
SPL
SPL Set ID 32cde708-aed4-2943-e063-6394a90ac715
Route
TOPICAL
Published
Effective Date 2025-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g) Niacinamide (0.2 g) Caffeine (0.3 g) Biotin
Inactive Ingredients
Rosemary Aqua Alcohol Propylene Glycol Glycerin Sodium Lauryl Glycol Carboxylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-15

Description

5% Minoxidil. 0.3% Biotin. 0.2% Niacinamide.. 0.2% Caffeine.

Purpose

Hair regrowth treatment Anti-hair loss Helps hair regrowth Anti-hair loss


Medication Information

Purpose

Hair regrowth treatment

Anti-hair loss

Helps hair regrowth

Anti-hair loss

Description

5% Minoxidil. 0.3% Biotin. 0.2% Niacinamide.. 0.2% Caffeine.

Use

Use to Regrow Hair on Scalp and Beard

Section 50565-1

Keep out of reach of children.

Section 50566-9

For external use only. Avoid contact with eyes.

If contact occurs, rinse thoroughly with water.

Section 50567-7

Discontinue use if any rritation or adverse reaction occurs.

Warnings

1. For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Keep out of reach of children.

2. Discontinue use if any rritation or adverse reaction occurs.

3. If you are pregnant, nursing, or have any underlying medical conditions, consult your

healthcare provider before using the product.

Directions

1. Apply half a capful twice a day to the scalp in the hair loss area. Massage into the scalp with

fingers, then wash hands well.

2. Using more or more often will not improve results. Continued use is necessary to increase

and maintain hair regrowth; otherwise, hair loss will begin again.

Do Not Use

Do not use on broken or irritated scalp.

Other Information

No Data

Active Ingredient(s)

5% Minoxidil.

0.3% Biotin.

0.2% Niacinamide..

0.2% Caffeine.

Inactive Ingredients

Aqua (Water), Alcohol, Glycerin, Propylene Glycol

Package Label Principal Display Panel


Structured Label Content

Use

Use to Regrow Hair on Scalp and Beard

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

For external use only. Avoid contact with eyes.

If contact occurs, rinse thoroughly with water.

Section 50567-7 (50567-7)

Discontinue use if any rritation or adverse reaction occurs.

Purpose

Hair regrowth treatment

Anti-hair loss

Helps hair regrowth

Anti-hair loss

Warnings

1. For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Keep out of reach of children.

2. Discontinue use if any rritation or adverse reaction occurs.

3. If you are pregnant, nursing, or have any underlying medical conditions, consult your

healthcare provider before using the product.

Directions

1. Apply half a capful twice a day to the scalp in the hair loss area. Massage into the scalp with

fingers, then wash hands well.

2. Using more or more often will not improve results. Continued use is necessary to increase

and maintain hair regrowth; otherwise, hair loss will begin again.

Do Not Use (Do not use)

Do not use on broken or irritated scalp.

Other Information (Other information)

No Data

Active Ingredient(s)

5% Minoxidil.

0.3% Biotin.

0.2% Niacinamide..

0.2% Caffeine.

Inactive Ingredients (Inactive ingredients)

Aqua (Water), Alcohol, Glycerin, Propylene Glycol

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)