SPL v1
SPL
SPL Set ID 41b745d7-6947-ec24-e063-6294a90aa467
Route
TOPICAL
Published
Effective Date 2025-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 mg)
Inactive Ingredients
Cetyl Alcohol Citric Acid Lactic Acid Dehydrated Alcohol Polysorbate 60 Ricinus Communis (castor) Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-11-08 Until 2026-11-11

Description

BIOTIN 5%


Medication Information

Warnings and Precautions

For external use only.For external use only Keep away from fire and flame

Indications and Usage

1.Massage the scalp to fully relax the scalp

2.Ad one or two drops to the scalp area to be used.

3. Apply evenly to the rest of the area.

4.Continue to use weice a day

Dosage and Administration

Twice each day,4 sprays (1ml)each time. 30 days supply

Description

BIOTIN 5%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50567-7

1. Do not apply on other parts of the body, For topical use only on the scalp

2. Avoid contact with the eyes in case of accidental contact rinse eyes with large arnounts of cool tap water.

3.Some people have experienced changes in hair color and'or texture.

4. The amount of hair rearowth is dlfferent for each person, This product will not work for all men.

Usage.1. Massage the scalp to fuly relaxthe scalp.2.Ad one ortwo dropsto the scap areato be used.3. Apply evenly to the rest ofthe area.4. Continue to use weice a day.

Fniendly reminder.it talkes time to regrow hail,it usually takes 45-60 days to see the effect, the speciflc effect will vary from person to person, some peole may need 90 days to see the effect

Section 50570-1

You have no family history of hair loss,hair loss is sudden and/or patchy

You do not know the reason for you hair loss.

You ae under 18 years of age, Do not use it on babies and children your scalp is red.inflamed.infected, irritated, or painful

You use other medicines on the scalp.Ask a doctor before use if you hace heart disease.

Section 51727-6

Cetyl Alcohol,Citric Acid ,Dehydrated Alcohol,Lactic Acid,Polysorbate 60,

Ricinus Communis (Castor) Seed Oil,Polygonum Multiflorum Root Extract,Zingiber Officinale (Ginger) Root Extract,Artemisia Vulgaris Extract,Ligusticum Chuanxiong Root Extract,Salvia Miltiorrhiza Root Extract,Angelica Polymorpha Sinensis Root Extract,Morus Nigra Fruit Extract,Panax Ginseng Root Extract,Houttuynia Cordata Extract,Carthamus Tinctorius (Safflower) Extract,Astragalus Membranaceus Root Extract,Camellia Japonica Seed Extract,Polygonatum Sibiricum Extract,Sophora Flavescens Root Extract,Panax Notoginseng Root Extract,Ganoderma Sinensis Extract,Portulaca Oleracea Extract,Cordyceps Sinensis Extract,Rehmannia Glutinosa Root Extract.

Section 51945-4

Section 55105-1

Anti-hair loss shampoo

Section 55106-9

BIOTIN 5%


Structured Label Content

Indications and Usage (34067-9)

1.Massage the scalp to fully relax the scalp

2.Ad one or two drops to the scalp area to be used.

3. Apply evenly to the rest of the area.

4.Continue to use weice a day

Dosage and Administration (34068-7)

Twice each day,4 sprays (1ml)each time. 30 days supply

Warnings and Precautions (34071-1)

For external use only.For external use only Keep away from fire and flame

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50567-7 (50567-7)

1. Do not apply on other parts of the body, For topical use only on the scalp

2. Avoid contact with the eyes in case of accidental contact rinse eyes with large arnounts of cool tap water.

3.Some people have experienced changes in hair color and'or texture.

4. The amount of hair rearowth is dlfferent for each person, This product will not work for all men.

Usage.1. Massage the scalp to fuly relaxthe scalp.2.Ad one ortwo dropsto the scap areato be used.3. Apply evenly to the rest ofthe area.4. Continue to use weice a day.

Fniendly reminder.it talkes time to regrow hail,it usually takes 45-60 days to see the effect, the speciflc effect will vary from person to person, some peole may need 90 days to see the effect

Section 50570-1 (50570-1)

You have no family history of hair loss,hair loss is sudden and/or patchy

You do not know the reason for you hair loss.

You ae under 18 years of age, Do not use it on babies and children your scalp is red.inflamed.infected, irritated, or painful

You use other medicines on the scalp.Ask a doctor before use if you hace heart disease.

Section 51727-6 (51727-6)

Cetyl Alcohol,Citric Acid ,Dehydrated Alcohol,Lactic Acid,Polysorbate 60,

Ricinus Communis (Castor) Seed Oil,Polygonum Multiflorum Root Extract,Zingiber Officinale (Ginger) Root Extract,Artemisia Vulgaris Extract,Ligusticum Chuanxiong Root Extract,Salvia Miltiorrhiza Root Extract,Angelica Polymorpha Sinensis Root Extract,Morus Nigra Fruit Extract,Panax Ginseng Root Extract,Houttuynia Cordata Extract,Carthamus Tinctorius (Safflower) Extract,Astragalus Membranaceus Root Extract,Camellia Japonica Seed Extract,Polygonatum Sibiricum Extract,Sophora Flavescens Root Extract,Panax Notoginseng Root Extract,Ganoderma Sinensis Extract,Portulaca Oleracea Extract,Cordyceps Sinensis Extract,Rehmannia Glutinosa Root Extract.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-hair loss shampoo

Section 55106-9 (55106-9)

BIOTIN 5%


Advanced Ingredient Data


Raw Label Data

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