85304-021 5% Minoxidil With Biotin Topical Solution

Drug Facts

Composition & Product

Active Ingredients

Biotin (0.5 g) Minoxidil (5 g)

Inactive Ingredients

Butylene Glycol Alcohol Panthenol Water Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-10-30

Medication Information

Warnings and Precautions

For external use only.

Keep out of reach of children.

Indications and Usage

Use to regrow hair of the scalp and beard growth for men

Dosage and Administration

Apply 3-6 drops Minoxidil Serum directly onto scalp on the hair loss area.

Use fingertips to massage solution into skin/hair for 1 minutes then wash hands thoroughly.

Used once daily on clean dry hair for best results.

Description

Minoxidil 5% Biotin 0.5%

Section 50565-1

Keep out of reach of children.

lf swallowed, get medical help or contact a Poison Control Center(1-800-222-1222)right away.

Section 50566-9

Chest pain, rapid heartbeat, faintness, or dizziness occurs.

Sudden, unexplained weight gain occurs.

Scalp irritation or redness occurs.

Section 50567-7

Avoid contact with eves. in case of accidental contact, rinse eves with a large amount of cool tap water.

Section 50570-1

You have no family history of hair loss.

Your hair loss is sudden and/or patchy.

Your hair loss is associated with childbirth.

You do not know the reason for your hair loss.

You are under 18 years of age. Do not use on babies and children.

Your scalp is red, inflamed, infected, irritated, or painful.

You use other medicines on the scalp.

Section 51727-6

Butylene glycol

Glycerin

Alcohol

Panthenol

Water

Section 51945-4

Section 55105-1

Hair Regrowth

Section 55106-9

Minoxidil 5%

Biotin 0.5%

Structured Label Content

Indications and Usage (34067-9)

Use to regrow hair of the scalp and beard growth for men

Dosage and Administration (34068-7)

Apply 3-6 drops Minoxidil Serum directly onto scalp on the hair loss area.

Use fingertips to massage solution into skin/hair for 1 minutes then wash hands thoroughly.

Used once daily on clean dry hair for best results.

Warnings and Precautions (34071-1)

For external use only.

Keep out of reach of children.

Section 50565-1 (50565-1)

Keep out of reach of children.

lf swallowed, get medical help or contact a Poison Control Center(1-800-222-1222)right away.

Section 50566-9 (50566-9)

Chest pain, rapid heartbeat, faintness, or dizziness occurs.

Sudden, unexplained weight gain occurs.

Scalp irritation or redness occurs.

Section 50567-7 (50567-7)

Avoid contact with eves. in case of accidental contact, rinse eves with a large amount of cool tap water.

Section 50570-1 (50570-1)

You have no family history of hair loss.

Your hair loss is sudden and/or patchy.

Your hair loss is associated with childbirth.

You do not know the reason for your hair loss.

You are under 18 years of age. Do not use on babies and children.

Your scalp is red, inflamed, infected, irritated, or painful.

You use other medicines on the scalp.

Section 51727-6 (51727-6)

Butylene glycol

Glycerin

Alcohol

Panthenol

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair Regrowth

Section 55106-9 (55106-9)

Minoxidil 5%

Biotin 0.5%

Advanced Ingredient Data

[{"name": "BIOTIN", "unii": "6SO6U10H04", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINOXIDIL", "unii": "5965120SH1", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PANTHENOL", "unii": "WV9CM0O67Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use to regrow hair of the scalp and beard growth for men", "34068-7": "Apply 3-6 drops Minoxidil Serum directly onto scalp on the hair loss area. Use fingertips to massage solution into skin/hair for 1 minutes then wash hands thoroughly. Used once daily on clean dry hair for best results.", "34071-1": "For external use only. Keep out of reach of children.", "50565-1": "Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center(1-800-222-1222)right away.", "50566-9": "Chest pain, rapid heartbeat, faintness, or dizziness occurs. Sudden, unexplained weight gain occurs. Scalp irritation or redness occurs.", "50567-7": "Avoid contact with eves. in case of accidental contact, rinse eves with a large amount of cool tap water.", "50570-1": "You have no family history of hair loss. Your hair loss is sudden and/or patchy. Your hair loss is associated with childbirth. You do not know the reason for your hair loss. You are under 18 years of age. Do not use on babies and children. Your scalp is red, inflamed, infected, irritated, or painful. You use other medicines on the scalp.", "51727-6": "Butylene glycol Glycerin Alcohol Panthenol Water", "55105-1": "Hair Regrowth", "55106-9": "Minoxidil 5% Biotin 0.5%"}