DailyMed - DailyMed Details

SPL v3

SPL

SPL Set ID 3c3f84da-c4bc-36ac-e063-6394a90aa8d1

Route

TOPICAL

Published

Effective Date 2025-08-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Minoxidil (5 mg)

Inactive Ingredients

Water Alcohol 50% Propylene Glycol 1,2-distearate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2025-08-13 Until 2027-08-12

Description

Apply 1ml (20 drops) one to two times a day to the beard or scalp area, which must be dry, massage lightly and then wash your hands. Do not remove or use dryers. ( Do not exceed the indicated amount)

Medication Information

Warnings and Precautions

Avoid eyes contact, if occurs, rinse with plenty of water. Do not apply to irritated scalp. If yoy experience any allergic reaction discard its use and consult your doctor. Do not eat.

Indications and Usage

Apply 1ml (20 drops) one to two times a day to the beard or scalp area, which must be dry, massage lightly and then wash your hands. Do not remove or use dryers. ( Do not exceed the indicated amount)

Dosage and Administration

Apply 1ml (20 drops) one to two times a day to the beard or scalp area.

Description

Apply 1ml (20 drops) one to two times a day to the beard or scalp area, which must be dry, massage lightly and then wash your hands. Do not remove or use dryers. ( Do not exceed the indicated amount)

Section 50565-1

Keep out of reach of children, for external use only.

Section 50744-2

Section 51727-6

Alcohol, Propylen Glycol, Purified Water.

Section 51945-4

Section 55105-1

Structured Label Content

Indications and Usage (34067-9)

Apply 1ml (20 drops) one to two times a day to the beard or scalp area, which must be dry, massage lightly and then wash your hands. Do not remove or use dryers. ( Do not exceed the indicated amount)

Dosage and Administration (34068-7)

Apply 1ml (20 drops) one to two times a day to the beard or scalp area.

Warnings and Precautions (34071-1)

Avoid eyes contact, if occurs, rinse with plenty of water. Do not apply to irritated scalp. If yoy experience any allergic reaction discard its use and consult your doctor. Do not eat.

Section 50565-1 (50565-1)

Keep out of reach of children, for external use only.

Section 50744-2 (50744-2)

Section 51727-6 (51727-6)

Alcohol, Propylen Glycol, Purified Water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINOXIDIL", "unii": "5965120SH1", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL 50%", "unii": "DW4WDF59AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL 1,2-DISTEARATE", "unii": "T65PN3O37H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Apply 1ml (20 drops) one to two times a day to the beard or scalp area, which must be dry, massage lightly and then wash your hands. Do not remove or use dryers. ( Do not exceed the indicated amount)", "34068-7": "Apply 1ml (20 drops) one to two times a day to the beard or scalp area.", "34071-1": "Avoid eyes contact, if occurs, rinse with plenty of water. Do not apply to irritated scalp. If yoy experience any allergic reaction discard its use and consult your doctor. Do not eat.", "50565-1": "Keep out of reach of children, for external use only.", "51727-6": "Alcohol, Propylen Glycol, Purified Water."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:53.070584 · Updated: 2026-03-14T23:09:55.704959