Gze 5% Minoxidil Solution

SPL v1

SPL

SPL Set ID 241b7f4f-f974-a64c-e063-6294a90a6856

Route

TOPICAL

Published

Effective Date 2024-10-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Minoxidil (5 g)

Inactive Ingredients

Water Propylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-09-19

Description

Minoxidil

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Apply one mL with spray 2X a day directly onto scalp in the needed area.

Dosage and Administration

Apply one mL with spray 2X a day directly onto scalp in the needed area.

Description

Minoxidil

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Aqua, Propylene Glycol

Section 51945-4

Section 55105-1

Hair growth.

Section 55106-9

Minoxidil

Structured Label Content

Indications and Usage (34067-9)

Apply one mL with spray 2X a day directly onto scalp in the needed area.

Dosage and Administration (34068-7)

Apply one mL with spray 2X a day directly onto scalp in the needed area.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Aqua, Propylene Glycol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair growth.

Section 55106-9 (55106-9)

Minoxidil

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINOXIDIL", "unii": "5965120SH1", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Apply one mL with spray 2X a day directly onto scalp in the needed area.", "34068-7": "Apply one mL with spray 2X a day directly onto scalp in the needed area.", "34071-1": "For external use only.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs.", "50567-7": "When using this product keep out of eyes. Rinse with water to remove.", "50570-1": "Do not use on damaged or broken skin.", "51727-6": "Aqua, Propylene Glycol", "55105-1": "Hair growth.", "55106-9": "Minoxidil"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:44.414585 · Updated: 2026-03-14T23:03:58.855522