84614-001 5% Minoxidil Hair Regrowth Serum With Biotin

84614-001 5% Minoxidil Hair Regrowth Serum With Biotin
SPL v2
SPL
SPL Set ID 1eae27bc-1b18-ae5d-e063-6394a90a4610
Route
TOPICAL
Published
Effective Date 2024-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g) Biotin (0.2 g)
Inactive Ingredients
Glycerin Water Alcohol Butylene Glycol Panthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-02
Description

5% MINOXIDIL HAIR REGROWTH SERUM With Biotin

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 washhands thoroughly.

Used once daily on clean dry hair for best results

Description

5% MINOXIDIL HAIR REGROWTH SERUM With Biotin

Section 42229-5

5% MINOXIDIL HAIR REGROWTH SERUM With Biotin

Section 44425-7

Before use, read all information on carton and enclosed leafletStore at controlled room temperature 10° to 30°C (50° to 80°F)Do not incinerate container. Do not expose toheat or store at temperature above 104°F(40°C)

Section 50565-1

Keep out of reach of children.

If 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.

Keep out of reach of children.

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

Section 50567-7

Avoid contact with eyes. In case of accidental contact, rinse eyes 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 0.2%

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 washhands 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 42229-5 (42229-5)

5% MINOXIDIL HAIR REGROWTH SERUM With Biotin

Section 44425-7 (44425-7)

Before use, read all information on carton and enclosed leafletStore at controlled room temperature 10° to 30°C (50° to 80°F)Do not incinerate container. Do not expose toheat or store at temperature above 104°F(40°C)

Section 50565-1 (50565-1)

Keep out of reach of children.

If 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.

Keep out of reach of children.

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

Section 50567-7 (50567-7)

Avoid contact with eyes. In case of accidental contact, rinse eyes 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 0.2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:59.273961 · Updated: 2026-03-14T23:10:07.372921