SPL v2
SPL
SPL Set ID 26cc22be-30f6-03da-e063-6394a90aafe7
Route
TOPICAL
Published
Effective Date 2024-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (50 mg)
Inactive Ingredients
1,2-hexanediol Myristoyl Pentapeptide-4 Propylene Glycol Glyceryl Caprylate Sodium Hyaluronate Alcohol Caprylhydroxamic Acid Sophora Flavescens Root Aqua Caffeine Acetyl Tetrapeptide-3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-13

Description

MINOXIDIL 5%


Medication Information

Warnings and Precautions

For external use only, avoid contact withthe eyes.lf symptoms of redness or allergy occur,discontinue use and consult a physician.

Indications and Usage

Make sure your hair and scalp are dry(noneed to wash your hair before each use).Spray the product on the topof yourscalp or on areas with thinning hair.* Gently massage into scalp or thinninghair areas until absorbed.

Dosage and Administration

Apply 2-3 drops of serum directly to thescalp in the area to be treated.Massage into the scalp with your fingersthen wash hands thoroughly..Continued use is necessary to increaseand then maintain your hair regrowth.*Discontinuing use may result in hair loss.

Description

MINOXIDIL 5%

Section 50565-1

You are under 18 years of age. Do not useit on babies and children,keep out of reach of childrean

Section 50566-9

Chest pain, ropid heart beatfaintness, or dizziness occurs suddenunexplained weight gain occurs yourhands or feet swel scolp inflamed orredness occurs Unanted focial hair

growth occurs.

Section 50567-7

When using this product

* Do not apply on other parts of the body*Avoid contact with eyes. in case ofaccidental contact, rinse eyes with a largeamount of cool tap water..lt takes time to regrow hair. You may needto use this product 2 times a day for at least4 months before you see results.*The amount of hair regrowth is differentfor each person.* The product will not work for everyone.

Section 51727-6

CAFFEINE

ACETYL TETRAPEPTIDE-3

MYRISTOYL PENTAPEPTIDE-4

1,2-HEXANEDIOL

SOPHORA FLAVESCENS ROOT EXTRACT

SODIUM HYALURONATE

AQUA

PROPYLENE GLYCOL

ALCOHOL

GLYCERYL CAPRYLATE

CAPRYLHYDROXAMIC ACID

Section 51945-4

Section 55105-1

REDUCE HAIR LOSS

NURSING SCALP

RESTORE THINNING HAIR

Section 55106-9

MINOXIDIL 5%


Structured Label Content

Indications and Usage (34067-9)

Make sure your hair and scalp are dry(noneed to wash your hair before each use).Spray the product on the topof yourscalp or on areas with thinning hair.* Gently massage into scalp or thinninghair areas until absorbed.

Dosage and Administration (34068-7)

Apply 2-3 drops of serum directly to thescalp in the area to be treated.Massage into the scalp with your fingersthen wash hands thoroughly..Continued use is necessary to increaseand then maintain your hair regrowth.*Discontinuing use may result in hair loss.

Warnings and Precautions (34071-1)

For external use only, avoid contact withthe eyes.lf symptoms of redness or allergy occur,discontinue use and consult a physician.

Section 50565-1 (50565-1)

You are under 18 years of age. Do not useit on babies and children,keep out of reach of childrean

Section 50566-9 (50566-9)

Chest pain, ropid heart beatfaintness, or dizziness occurs suddenunexplained weight gain occurs yourhands or feet swel scolp inflamed orredness occurs Unanted focial hair

growth occurs.

Section 50567-7 (50567-7)

When using this product

* Do not apply on other parts of the body*Avoid contact with eyes. in case ofaccidental contact, rinse eyes with a largeamount of cool tap water..lt takes time to regrow hair. You may needto use this product 2 times a day for at least4 months before you see results.*The amount of hair regrowth is differentfor each person.* The product will not work for everyone.

Section 51727-6 (51727-6)

CAFFEINE

ACETYL TETRAPEPTIDE-3

MYRISTOYL PENTAPEPTIDE-4

1,2-HEXANEDIOL

SOPHORA FLAVESCENS ROOT EXTRACT

SODIUM HYALURONATE

AQUA

PROPYLENE GLYCOL

ALCOHOL

GLYCERYL CAPRYLATE

CAPRYLHYDROXAMIC ACID

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

REDUCE HAIR LOSS

NURSING SCALP

RESTORE THINNING HAIR

Section 55106-9 (55106-9)

MINOXIDIL 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)