Probliva Men's Extra Strength 5% Minoxidil Topical Solution

Probliva Men's Extra Strength 5% Minoxidil Topical Solution
SPL v1
SPL
SPL Set ID 84a2f311-e74c-4b50-bc55-dac604ca7694
Route
TOPICAL
Published
Effective Date 2025-04-17
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 2025-04-04

Description

Minoxidil 5% w/v

Purpose

Hair regrowth treatment for men


Medication Information

Purpose

Hair regrowth treatment for men

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.

FlammableKeep away from fire or flame

Directions

• prime the sprayer by holding the bottle upright and 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

Drug Facts

Do Not Use If:

• you are a woman • you have no family history of hair loss • your hair loss is sudden and/or patchy • you do not know the reason for your 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

• 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 treament 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 20° to 25°C (68° to 77°F).

Package Labeling:

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments?

1-718-2907390 • Visit Website at www.problivabeauty.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 • unwated facial hair growth occurs

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

Use

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

Purpose

Hair regrowth treatment for men

Warnings

For external use only. For use by men only.

FlammableKeep away from fire or flame

Directions

• prime the sprayer by holding the bottle upright and 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

Drug Facts

Do Not Use If: (Do not use if:)

• you are a woman • you have no family history of hair loss • your hair loss is sudden and/or patchy • you do not know the reason for your 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)

• 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 treament 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 20° to 25°C (68° to 77°F).

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments? (Questions or comments?)

1-718-2907390 • Visit Website at www.problivabeauty.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 • unwated facial hair growth occurs

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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