5%minoxidil Hair Growth Serum

SPL v1

SPL

SPL Set ID 2f7ec62f-fad5-6862-e063-6394a90abe54

Route

TOPICAL

Published

Effective Date 2025-03-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Minoxidil (5 g) Caffeine (0.2 g) Biotin (0.3 g) Niacinamide

Inactive Ingredients

Water Alcohol Propylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-03-04

Description

Minoxidil 5% Biotin 0.3% Niacinamide 0.2% Caffeine 0.2%

Medication Information

Warnings and Precautions

For extemal use only.

Avoid contactwith eyes. lf contact occurs, rinse thoroughlywith water.

Indications and Usage

Use: To regrow hair of scalp and beard

Dosage and Administration

Directions: Apply twice daily (morning andnight) as a man and once as a woman. Afterapplication, proceed with an active scalpmassage for 3-5 minutes until the product isfully absorbed.

Description

Minoxidil 5% Biotin 0.3% Niacinamide 0.2% Caffeine 0.2%

Section 50565-1

Keep out of reach of Children.

Section 50566-9

Discontinue use if any irritation or adversereaction occurs.

Section 50567-7

When Using Section: When using this productavoid contact with eyes. lf contact occurs.rinse thoroughly with water.

Section 50570-1

Do not use: On broken or irritated scalp

Section 51727-6

Water

Alcohol

Propylene Glycol

Section 51945-4

Section 55105-1

Hair regrowth treatment

Section 55106-9

Minoxidil 5%

Biotin 0.3%

Niacinamide 0.2%

Caffeine 0.2%

Structured Label Content

Indications and Usage (34067-9)

Use: To regrow hair of scalp and beard

Dosage and Administration (34068-7)

Directions: Apply twice daily (morning andnight) as a man and once as a woman. Afterapplication, proceed with an active scalpmassage for 3-5 minutes until the product isfully absorbed.

Warnings and Precautions (34071-1)

For extemal use only.

Avoid contactwith eyes. lf contact occurs, rinse thoroughlywith water.

Section 50565-1 (50565-1)

Keep out of reach of Children.

Section 50566-9 (50566-9)

Discontinue use if any irritation or adversereaction occurs.

Section 50567-7 (50567-7)

When Using Section: When using this productavoid contact with eyes. lf contact occurs.rinse thoroughly with water.

Section 50570-1 (50570-1)

Do not use: On broken or irritated scalp

Section 51727-6 (51727-6)

Water

Alcohol

Propylene Glycol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair regrowth treatment

Section 55106-9 (55106-9)

Minoxidil 5%

Biotin 0.3%

Niacinamide 0.2%

Caffeine 0.2%

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINOXIDIL", "unii": "5965120SH1", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CAFFEINE", "unii": "3G6A5W338E", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BIOTIN", "unii": "6SO6U10H04", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use: To regrow hair of scalp and beard", "34068-7": "Directions: Apply twice daily (morning andnight) as a man and once as a woman. Afterapplication, proceed with an active scalpmassage for 3-5 minutes until the product isfully absorbed.", "34071-1": "For extemal use only. Avoid contactwith eyes. lf contact occurs, rinse thoroughlywith water.", "50565-1": "Keep out of reach of Children.", "50566-9": "Discontinue use if any irritation or adversereaction occurs.", "50567-7": "When Using Section: When using this productavoid contact with eyes. lf contact occurs.rinse thoroughly with water.", "50570-1": "Do not use: On broken or irritated scalp", "51727-6": "Water Alcohol Propylene Glycol", "55105-1": "Hair regrowth treatment", "55106-9": "Minoxidil 5% Biotin 0.3% Niacinamide 0.2% Caffeine 0.2%"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:39.929408 · Updated: 2026-03-14T23:07:49.806657