SPL v1
SPL
SPL Set ID 22fc6a5f-a07e-450a-e063-6394a90a943a
Route
CUTANEOUS
Published
Effective Date 2024-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (1 mg)
Inactive Ingredients
Niacinamide Polysorbate 20 Water Acetic Acid Panthenol Dimethyl Isosorbide Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-26

Description

Minoxidil;


Medication Information

Warnings and Precautions

Do not apply on other parts ofthe body Avoid contact with eyes. In case ofaccidental contact, rinse eyes witha large amount of cool tap water.

Indications and Usage

1.Apply 2-3 drops of serum directly tothescalp in the area to be treated.

2.Massage into the scalp with yourfngersthen wash hands thoroughly.

3.Using more hair regrowth serumorusing the serum more often willnotimprove your results.

4.Continued use is necessary to increaseand then maintain your hair regrowth.

5.Discontinuing use may result inhair loss.

Dosage and Administration

lt takes time to regrow hairYou mayneed to use this product 2times a day forat least 4 months beforeyou see results,The amount of hair regrowth is different for each person.The product will not work for everyone.

Description

Minoxidil;

Section 50565-1



KEEP THE PRODUCT OUT OF REACH OF CHILDREN to

Section 50566-9



This product may cause allergic reactions in asmall number of people.

lf youexperience any discomfort,please stop using it immediately.

Section 50570-1



Not suitable for use by children, pregnantor breast feeding people.

Section 51727-6

Dimethyl Isosorbide

Niacinamide,Polysorbate 20:

Propylene Glycol,Water,

Acetic Acid,Panthenol.

Section 51945-4

Section 55105-1

1.Reactivates Hair Follicles

2.Grow Stronger and Thicker Hair

3.Help Regrow Hair

Section 55106-9

Minoxidil;


Structured Label Content

Indications and Usage (34067-9)

1.Apply 2-3 drops of serum directly tothescalp in the area to be treated.

2.Massage into the scalp with yourfngersthen wash hands thoroughly.

3.Using more hair regrowth serumorusing the serum more often willnotimprove your results.

4.Continued use is necessary to increaseand then maintain your hair regrowth.

5.Discontinuing use may result inhair loss.

Dosage and Administration (34068-7)

lt takes time to regrow hairYou mayneed to use this product 2times a day forat least 4 months beforeyou see results,The amount of hair regrowth is different for each person.The product will not work for everyone.

Warnings and Precautions (34071-1)

Do not apply on other parts ofthe body Avoid contact with eyes. In case ofaccidental contact, rinse eyes witha large amount of cool tap water.

Section 50565-1 (50565-1)



KEEP THE PRODUCT OUT OF REACH OF CHILDREN to

Section 50566-9 (50566-9)



This product may cause allergic reactions in asmall number of people.

lf youexperience any discomfort,please stop using it immediately.

Section 50570-1 (50570-1)



Not suitable for use by children, pregnantor breast feeding people.

Section 51727-6 (51727-6)

Dimethyl Isosorbide

Niacinamide,Polysorbate 20:

Propylene Glycol,Water,

Acetic Acid,Panthenol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

1.Reactivates Hair Follicles

2.Grow Stronger and Thicker Hair

3.Help Regrow Hair

Section 55106-9 (55106-9)

Minoxidil;


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)