83804-109

83804-109
SPL v1
SPL
SPL Set ID 1505286b-8e59-71df-e063-6294a90a54f2
Route
TOPICAL
Published
Effective Date 2023-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Vitamin A Asian Ginseng Polygonatum Multiflorum Root Ligusticum Sinense Subsp. Chuanxiong Root Biotin Water Platycladus Orientalis Leaf Safflower Angelica Sinensis Root Oil Cordia Dichotoma Whole

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-12-12

Description

Minoxidil 5%

Purpose

Hair Regrowth Treatment


Medication Information

Purpose

Hair Regrowth Treatment

Description

Minoxidil 5%

Use

to regrow hair on the top of the scalp

Stop Use

chest pain, rapid heart beat, faintness, or dizziness occurs

sudden, unexplained weight gain occurs

your hands or feet swell

scalp irritation or redness occurs

Warnings

For external use only

Keep away from fire and flame

Avoid contact with eyes

Questions
Ask Doctor

When Pregnant or breast-feeding

Directions

1. Apply 1 ML(few drops) directly onto scalp on the hairloss area.

2. Use fingertips to massage solution into skinjhair for2-3 minutes.

3. Allow time for hair tofully absorb Growth Oil For bestresults, use twice daily on clean dry hair

Do Not Use

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

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

When Using

Do not apply on other parts of the body

void contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water

It takes time to regrow hair. You may need to use this product 2 times a day for a least 4 months before you see results, The amount of hair regrowth is different for each person

Active Ingredient

Minoxidil 5%

Other Information

Before use, read all information on the carton

Store at controlled room temperature 20 to 25 C (68 to 77°F)

Inactive Ingredients

Biotin

Vitamin H

Water

Ginseng Extroct

polygonum multiflorum Thunb

Angelica Sinensis

Cacumen Platycladi Orientalis

Carthamus Tinctorius L Extract

Ligusticum Chuanxiong Hort Extract

Cortex Dictamni

Principal Display Panel

Keep Oot of Reach of Children

When Pregnant or breast-feeding


Structured Label Content

Use

to regrow hair on the top of the scalp

Purpose

Hair Regrowth Treatment

Stop Use

chest pain, rapid heart beat, faintness, or dizziness occurs

sudden, unexplained weight gain occurs

your hands or feet swell

scalp irritation or redness occurs

Warnings

For external use only

Keep away from fire and flame

Avoid contact with eyes

Questions
Ask Doctor

When Pregnant or breast-feeding

Directions

1. Apply 1 ML(few drops) directly onto scalp on the hairloss area.

2. Use fingertips to massage solution into skinjhair for2-3 minutes.

3. Allow time for hair tofully absorb Growth Oil For bestresults, use twice daily on clean dry hair

Do Not Use (Do not use)

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

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

When Using

Do not apply on other parts of the body

void contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water

It takes time to regrow hair. You may need to use this product 2 times a day for a least 4 months before you see results, The amount of hair regrowth is different for each person

Active Ingredient

Minoxidil 5%

Other Information (Other information)

Before use, read all information on the carton

Store at controlled room temperature 20 to 25 C (68 to 77°F)

Inactive Ingredients (Inactive ingredients)

Biotin

Vitamin H

Water

Ginseng Extroct

polygonum multiflorum Thunb

Angelica Sinensis

Cacumen Platycladi Orientalis

Carthamus Tinctorius L Extract

Ligusticum Chuanxiong Hort Extract

Cortex Dictamni

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

When Pregnant or breast-feeding


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)