84432-001

84432-001
SPL v1
SPL
SPL Set ID 1b20dc4b-b2a2-e405-e063-6394a90af7ed
Route
TOPICAL
Published
Effective Date 2024-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Ligusticum Sinense Subsp. Chuanxiong Root Arctium Lappa Root Fallopia Multiflora Root Capsaicin Water Biotin Collagen Alpha-1(i) Chain Bovine Panax Japonicus Root Ginger Safflower Dictamnine Angelica Sinensis Root Alcohol Licorice Platycladus Orientalis Leaf

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-06-18

Description

minoxidil 5%

Purpose

Hair regrowth treatment for men


Medication Information

Purpose



Hair regrowth treatment for men



Description

minoxidil 5%

Use

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)



Section 50565-1

Keep out of reach of children. If swallowed, get medical help or

oontact a Poison Control Center right away



Section 50566-9

■chest pain, rapid heartbeat, faintness, or dizziness occur

■sudden, unexplained weight gain occurs

■your hands or feet swell

■scalp initation or redness occurs

■unwanted facial hair growthoocurs

■youdo not see hair regrowth in 4 months



Section 50567-7

■donot apply on other parts of the body

■avoid contact with the eyes. In case of accidental contact, rinse

eyes with large amounts of tap water.

■some people have experienced changes in hair color and texture

it takes time to regrow hair. Results may occur at 2 months with

twice a day usage. For some men, you may need to use this

product for 4 months before you see results.

■the amount of hair regrowth is different for each person. This

product will not work for all men.



Warnings

For extermal use only. For use by men only.

Flammable: Keep away from fire or flame



Directions

■apply one mLwith dropper 2 times a day direty onto the scalpin the hair loss

■using more or more often will not improve results

■continued use is neoessary to increase and keep your hair

regrowth, or hair loss will begin again



Do Not Use

■youare a woman

■your amount of hair loss is diferent than that shown on the sideof

this carton or your hair loss is on the front of the scalp. Minoxidil

topical solution 5% is not intended for frontal baldness or receding

hairlineyou have no family history of hair loss

■yourhair loss is suddenor patchy

■youdo not knowthe reason for your hair less

■youareunder 18years of age. Do notuse on babies and

children.

■yourscalp is red, inflamed, infected, itated or painful

■youuse other medicines onthe scalp



Other Information

■see hair loss pictures on side of this carton

■before use, read all information on carton and enclosed lealflet

■keepthe carton. It contains important infomation.

■hair regrowth has not been shown to last longer than 48 weeks in

large dlinical trials with continuous treatment with minoxidil topical solution 5% for men

■indlinical studies with mosty white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for

men provided more hair regrowth than minoxidil topical solution 2%

■store at20° to 25°C (68° to 77°F). Keep tightyclosed.



Active Ingredient(s)

minoxidil 5%

Inactive Ingredients

aqua, biotin, ollagen, panax ginseng extract ginger extract, safflower extract, cortex dictamni extract, ligusticum chuanxiong

extract, licorioe extract, burdock root extract, angelica sinensis root extract, platycladus orientalis leaf extract, polygonum

muliflorum root extract, aloohol, capsaicin



Package Label Principal Display Panel


Structured Label Content

Use

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)



Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or

oontact a Poison Control Center right away



Section 50566-9 (50566-9)

■chest pain, rapid heartbeat, faintness, or dizziness occur

■sudden, unexplained weight gain occurs

■your hands or feet swell

■scalp initation or redness occurs

■unwanted facial hair growthoocurs

■youdo not see hair regrowth in 4 months



Section 50567-7 (50567-7)

■donot apply on other parts of the body

■avoid contact with the eyes. In case of accidental contact, rinse

eyes with large amounts of tap water.

■some people have experienced changes in hair color and texture

it takes time to regrow hair. Results may occur at 2 months with

twice a day usage. For some men, you may need to use this

product for 4 months before you see results.

■the amount of hair regrowth is different for each person. This

product will not work for all men.



Purpose



Hair regrowth treatment for men



Warnings

For extermal use only. For use by men only.

Flammable: Keep away from fire or flame



Directions

■apply one mLwith dropper 2 times a day direty onto the scalpin the hair loss

■using more or more often will not improve results

■continued use is neoessary to increase and keep your hair

regrowth, or hair loss will begin again



Do Not Use (Do not use)

■youare a woman

■your amount of hair loss is diferent than that shown on the sideof

this carton or your hair loss is on the front of the scalp. Minoxidil

topical solution 5% is not intended for frontal baldness or receding

hairlineyou have no family history of hair loss

■yourhair loss is suddenor patchy

■youdo not knowthe reason for your hair less

■youareunder 18years of age. Do notuse on babies and

children.

■yourscalp is red, inflamed, infected, itated or painful

■youuse other medicines onthe scalp



Other Information (Other information)

■see hair loss pictures on side of this carton

■before use, read all information on carton and enclosed lealflet

■keepthe carton. It contains important infomation.

■hair regrowth has not been shown to last longer than 48 weeks in

large dlinical trials with continuous treatment with minoxidil topical solution 5% for men

■indlinical studies with mosty white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for

men provided more hair regrowth than minoxidil topical solution 2%

■store at20° to 25°C (68° to 77°F). Keep tightyclosed.



Active Ingredient(s)

minoxidil 5%

Inactive Ingredients (Inactive ingredients)

aqua, biotin, ollagen, panax ginseng extract ginger extract, safflower extract, cortex dictamni extract, ligusticum chuanxiong

extract, licorioe extract, burdock root extract, angelica sinensis root extract, platycladus orientalis leaf extract, polygonum

muliflorum root extract, aloohol, capsaicin



Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)