SPL v2
SPL
SPL Set ID e301800b-c82a-c796-e053-2a95a90aa60c
Route
TOPICAL
Published
Effective Date 2022-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Platycladus Orientalis Seed Reynoutria Multiflora Root Water Capsaicin Ginger Biotin Alcohol Ligusticum Sinense Subsp. Chuanxiong Root Arctium Lappa Whole Glycyrrhiza Uralensis Root Fraxinus Excelsior Bark Angelica Sinensis Root Safflower

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-07-08

Description

Minoxidil 5% w/v

Purpose

Promotes hair growth


Medication Information

Purpose

Promotes hair growth

Description

Minoxidil 5% w/v

Use

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

Warnings

For external use only

Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

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 If
  • you are a pregnant women
  • you have open skin wounds
  • your amount of hair loss is different than that shown on the side of 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 hairline.
  • 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
Active Ingredient

Minoxidil 5% w/v

Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

water, vitamin H (biotin), alcohol, ginger extract, carthamus tinctorius (safflower) flower extract, fraxinus excelsior bark extract, fructus acerola extract, ligusticum chuanxiong root extract, glycyrrhiza uralensis (licorice) root extract, arctium lappa langelica sinensis root extract, thuja orientalis seed extract, polygonum multiflorum root extract, capsaicin

For More Information:

1-858-859-0969

Principal Display Panel

When Using This Product
  • 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 people you may need to use this product for at least 4 months before you see results.
  • the amount of hair regrowth is different for each person.This product will not work for all people.

Stop Use and Ask A Doctor If
  • 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

Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Have

heart disease


Structured Label Content

Use

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

Purpose

Promotes hair growth

Warnings

For external use only

Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

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 If (Do not use if)
  • you are a pregnant women
  • you have open skin wounds
  • your amount of hair loss is different than that shown on the side of 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 hairline.
  • 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
Active Ingredient (Active ingredient)

Minoxidil 5% w/v

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

water, vitamin H (biotin), alcohol, ginger extract, carthamus tinctorius (safflower) flower extract, fraxinus excelsior bark extract, fructus acerola extract, ligusticum chuanxiong root extract, glycyrrhiza uralensis (licorice) root extract, arctium lappa langelica sinensis root extract, thuja orientalis seed extract, polygonum multiflorum root extract, capsaicin

For More Information:

1-858-859-0969

Principal Display Panel

When Using This Product (When using this product)
  • 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 people you may need to use this product for at least 4 months before you see results.
  • the amount of hair regrowth is different for each person.This product will not work for all people.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

heart disease


Advanced Ingredient Data


Raw Label Data

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