83804-104

83804-104
SPL v1
SPL
SPL Set ID 103b81d7-402c-2239-e063-6294a90a7aff
Route
TOPICAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-30

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 heartbeat, faintness, or dizziness occurs

• sudden, unexplained weight gain occurs

• your hands or feet swell

• scalp irritation or redness occurs

• unwanted facial hair growth occurs

• you do not see hair regrowth in 4 months

May be harmful if used when pregnant or breast-feeding

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

Warnings

For external use only.

Flammable: Keep away from fire or flame

Questions
Ask Doctor

When Pregnant or breast-feeding

Directions

• apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area

• using more or more often will not improve results

• continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Do Not Use

• you have no family history of hair loss

• your hair loss is sudden and/or patchy

• 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

When Using

• do not apply on other parts of the body

• avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.

• some people have experienced changes in hair color and/or 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 at least 4 months before you see results.



Active Ingredient

Minoxidil 5%

Other Information

• see hair loss pictures on side of this carton

• before use, read all information on carton and enclosed leaflet

• keep the carton. It contains important information.

• hair regrowth has not been shown to last longer than 48 weeks in large clincial trials with continuous treatment with minoxidil topical solution 5% for men

• in clincial studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men proided more hair regrowth than minoxidil topical solution 2%

• store at 20-25° C (68-77° F). Keep tightly closed.

Inactive Ingredients

Biotin

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

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


Structured Label Content

Use

to regrow hair on the top of the scalp

Purpose

Hair Regrowth Treatment

Stop Use

• chest pain, rapid heartbeat, faintness, or dizziness occurs

• sudden, unexplained weight gain occurs

• your hands or feet swell

• scalp irritation or redness occurs

• unwanted facial hair growth occurs

• you do not see hair regrowth in 4 months

May be harmful if used when pregnant or breast-feeding

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

Warnings

For external use only.

Flammable: Keep away from fire or flame

Questions
Ask Doctor

When Pregnant or breast-feeding

Directions

• apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area

• using more or more often will not improve results

• continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Do Not Use (Do not use)

• you have no family history of hair loss

• your hair loss is sudden and/or patchy

• 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

When Using

• do not apply on other parts of the body

• avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.

• some people have experienced changes in hair color and/or 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 at least 4 months before you see results.



Active Ingredient

Minoxidil 5%

Other Information (Other information)

• see hair loss pictures on side of this carton

• before use, read all information on carton and enclosed leaflet

• keep the carton. It contains important information.

• hair regrowth has not been shown to last longer than 48 weeks in large clincial trials with continuous treatment with minoxidil topical solution 5% for men

• in clincial studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men proided more hair regrowth than minoxidil topical solution 2%

• store at 20-25° C (68-77° F). Keep tightly closed.

Inactive Ingredients (Inactive ingredients)

Biotin

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)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)