etaderm men’s minoxidil 5% hair regrowth treatment extra strength

etaderm men’s minoxidil 5% hair regrowth treatment extra strength
SPL v1
SPL
SPL Set ID fb838abf-43bf-4f7d-af78-18b7145946f4
Route
topical
Published
Effective Date 2025-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
minoxidil (50 mg)
Inactive Ingredients
alcohol propylene glycol water

Identifiers & Packaging

Marketing Status
anda active Since 2025-08-29

Purpose

Hair regrowth treatment for men

Description

Minoxidil 5% w/v


Medication Information

Purpose

Hair regrowth treatment for men

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 clinical trials with continuous treatment with 5% minoxidil topical solution for men • in clinical studies of mostly white men aged 18-45 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution • store at controlled room temperature 20º to 25ºC (68º to 77ºF).

Description

Minoxidil 5% w/v

Use

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

Warnings:

For external use only. For use by men only. Flammable:Keep away from fire or flame

Drug Facts

Directions:

• prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist • apply one mL  with spray (6 sprays) 2 times a daydirectly 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 woman • 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. 5% minoxidil topical solution 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, irritated or painful • you use other medicines on the scalp

Active Ingredient

Minoxidil 5% w/v

Package Labeling:

Inactive Ingredients:

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments?

(424) 354-4370

  • Visit Website at www.etaderm.com
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 men, 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 men.

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.

Ask A Doctor Before Use If You Have

heart disease

May Be Harmful If Used When Pregnant Or Breast Feeding.


Structured Label Content

Purpose

Hair regrowth treatment for men

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 clinical trials with continuous treatment with 5% minoxidil topical solution for men • in clinical studies of mostly white men aged 18-45 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution • store at controlled room temperature 20º to 25ºC (68º to 77ºF).

Use

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

Warnings:

For external use only. For use by men only. Flammable:Keep away from fire or flame

Drug Facts

Directions:

• prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist • apply one mL  with spray (6 sprays) 2 times a daydirectly 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 woman • 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. 5% minoxidil topical solution 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, irritated or painful • you use other medicines on the scalp

Active Ingredient (Active ingredient)

Minoxidil 5% w/v

Package Labeling:

Inactive Ingredients:

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments? (Questions or comments?)

(424) 354-4370

  • Visit Website at www.etaderm.com
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 men, 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 men.

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.

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

heart disease

May Be Harmful If Used When Pregnant Or Breast Feeding. (May be harmful if used when pregnant or breast-feeding.)


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