83910-002

83910-002
SPL v1
SPL
SPL Set ID 0e071e03-d44d-5bc7-e063-6394a90a9804
Route
TOPICAL
Published
Effective Date 2024-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Platycladus Orientalis Leaf Ligustrum Lucidum Fruit Ligusticum Sinense Subsp. Chuanxiong Root Glycyrrhiza Uralensis Whole Capsaicin Niacinamide Panthenol Rosemary Oil Water Polygonatum Multiflorum Root Angelica Sinensis Root Oil Biotin Asian Ginseng Carthamus Tinctorius Whole Dictamnus Dasycarpus Root Bark Castor Oil Oenocarpus Bataua Seed Oil

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-01-02

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

Stop use and ask a doctor if

chest pain, rapid heart beat, faintness, ordizziness occurs

sudden, unexplained weight gain occurs.

your hands or feet swell

scalp irritation or redness occurs

you get unwanted facial hair growth

you do not see hair regrowth in 4 months

Warnings

For external use only

Questions
Ask Doctor

Stop use and ask a doctor if

chest pain, rapid heart beat, faintness, ordizziness occurs

sudden, unexplained weight gain occurs.

your hands or feet swell

scalp irritation or redness occurs

you get unwanted facial hair growth

you do not see hair regrowth in 4 months

Directions



Apply 1 ml directly to scalp in the area to be treated Massage into the scalp with your fingers then wash hands thoroughly

Using more hair regrowth serum or using the serum more often will not improve your results Continued use is necessary to increase andmaintain your hair regrowth, or your hair loss willbegin 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 eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.

lt takes time to regrow hair. You may need to use this product twice a day and for a least 4 months before you see results.

The amount of hair regrowth is different for each person. This product will not work for everyone.

Active Ingredient

Minoxidil 5%

Other Information

Before use, read all information on this carton

Keep the carton. It contains important information.

Store at 20 to 25℃ (68 to 77°F).

Contents are under pressure. Avoid puncturing orincinerating. Keep away from heat, and storebelow 120°F (49℃).

Inactive Ingredients

Water, Alcohol, Biotin, Niacinamide, Panthenol, Jamaican Black Castor Oil, Rosemary Oil, Batana Oil, Ginseng Extract, Ginger Extract, Carthamus Tinctorius L. Extract, Cortex Dictamni, Fructus Ligustri Lucidi Extract, Ligusticum Chuanxiong Hort Extract, Glycyrrhiza Uralensis Fisch Extract, Arctium Lappa L., Angelica Sinensis, Cacumen Platycladi Orientalis P.E., Polygonum Multiflorum Thunb, Capsaicin, Collagen.

Principal Display Panel

Keep Oot of Reach of Children

Keep out of reach of children

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


Structured Label Content

Use

to regrow hair on the top of the scalp

Purpose

Hair regrowth treatment

Stop Use

Stop use and ask a doctor if

chest pain, rapid heart beat, faintness, ordizziness occurs

sudden, unexplained weight gain occurs.

your hands or feet swell

scalp irritation or redness occurs

you get unwanted facial hair growth

you do not see hair regrowth in 4 months

Warnings

For external use only

Questions
Ask Doctor

Stop use and ask a doctor if

chest pain, rapid heart beat, faintness, ordizziness occurs

sudden, unexplained weight gain occurs.

your hands or feet swell

scalp irritation or redness occurs

you get unwanted facial hair growth

you do not see hair regrowth in 4 months

Directions



Apply 1 ml directly to scalp in the area to be treated Massage into the scalp with your fingers then wash hands thoroughly

Using more hair regrowth serum or using the serum more often will not improve your results Continued use is necessary to increase andmaintain your hair regrowth, or your hair loss willbegin 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 eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.

lt takes time to regrow hair. You may need to use this product twice a day and for a least 4 months before you see results.

The amount of hair regrowth is different for each person. This product will not work for everyone.

Active Ingredient

Minoxidil 5%

Other Information (Other information)

Before use, read all information on this carton

Keep the carton. It contains important information.

Store at 20 to 25℃ (68 to 77°F).

Contents are under pressure. Avoid puncturing orincinerating. Keep away from heat, and storebelow 120°F (49℃).

Inactive Ingredients (Inactive ingredients)

Water, Alcohol, Biotin, Niacinamide, Panthenol, Jamaican Black Castor Oil, Rosemary Oil, Batana Oil, Ginseng Extract, Ginger Extract, Carthamus Tinctorius L. Extract, Cortex Dictamni, Fructus Ligustri Lucidi Extract, Ligusticum Chuanxiong Hort Extract, Glycyrrhiza Uralensis Fisch Extract, Arctium Lappa L., Angelica Sinensis, Cacumen Platycladi Orientalis P.E., Polygonum Multiflorum Thunb, Capsaicin, Collagen.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Keep out of reach of children

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


Advanced Ingredient Data


Raw Label Data

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