SPL v3
SPL
SPL Set ID 3ce73d95-3199-1ca3-e063-6394a90a2207
Route
TOPICAL
Published
Effective Date 2025-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (1 mg)
Inactive Ingredients
Ginger Citric Acid Propylene Glycol 1,2-distearate Peppermint Sodium Chloride Sodium Lauryl Sulfate Cocamide Mea .alpha.-(.alpha.-aminopropyl)benzyl Alcohol Hydrochloride, Erythro-(+/-)- Water Methylchloroisothiazolinone Methylisothiazolinone Betaine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-08-20 Until 2027-08-06
Description

Apply and massage on wet beard, hair or scalp for a few minutes, lather and rinse, repeat process if necessary

Medication Information

Warnings and Precautions

Avoid eye contact, if occurs rinse eyes thoroughly. Do not apply to irritated scalp. If have any allergic reaction, discard its use.

Indications and Usage

Apply and massage on wet beard, hair or scalp for a few minutes, lather and rinse, repeat process if necessary

Dosage and Administration

Apply and massage on wet beard, hair or scalp for a few minutes, lather and rinse, repeat process if necessary

Description

Apply and massage on wet beard, hair or scalp for a few minutes, lather and rinse, repeat process if necessary

Section 50565-1

Keep out reach of children, for external use only.

Section 50744-2

Customer Service USA (917)508-6002

Customer Service RD (809)379-0900

www.mkcosmeticos.com

Section 51727-6

Purified Water, Sodium Lauryl Sulfate, Cocamide MEA, Cocamidopropyl Betaine, Propylene Glycol,

Ginger Root Extract, Peppermint Extract, Sodium Chloride, Citric Acid, Benzyl Alcohol (and) Methylchloroisothiazolinone (and) Methylisothiazolinone

Section 51945-4

This is the principal panel display side of the minoxidil HAIR GROWTH SHAMPOO 1%

Section 55105-1

growth and help prevent hair and beard loss. Revitalizes hair follicles and stimulates growth. it is mentioned at the front side of the box and also in the indications & usage section.

Structured Label Content

Indications and Usage (34067-9)

Apply and massage on wet beard, hair or scalp for a few minutes, lather and rinse, repeat process if necessary

Dosage and Administration (34068-7)

Apply and massage on wet beard, hair or scalp for a few minutes, lather and rinse, repeat process if necessary

Warnings and Precautions (34071-1)

Avoid eye contact, if occurs rinse eyes thoroughly. Do not apply to irritated scalp. If have any allergic reaction, discard its use.

Section 50565-1 (50565-1)

Keep out reach of children, for external use only.

Section 50744-2 (50744-2)

Customer Service USA (917)508-6002

Customer Service RD (809)379-0900

www.mkcosmeticos.com

Section 51727-6 (51727-6)

Purified Water, Sodium Lauryl Sulfate, Cocamide MEA, Cocamidopropyl Betaine, Propylene Glycol,

Ginger Root Extract, Peppermint Extract, Sodium Chloride, Citric Acid, Benzyl Alcohol (and) Methylchloroisothiazolinone (and) Methylisothiazolinone

Section 51945-4 (51945-4)

This is the principal panel display side of the minoxidil HAIR GROWTH SHAMPOO 1%

Section 55105-1 (55105-1)

growth and help prevent hair and beard loss. Revitalizes hair follicles and stimulates growth. it is mentioned at the front side of the box and also in the indications & usage section.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:53.078685 · Updated: 2026-03-14T23:09:55.704959