Men's Rogaine ®
ccaecec5-5348-4b24-9190-5464c50f6d80
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Hair regrowth treatment for men
Medication Information
Purpose
Hair regrowth treatment for men
Description
Drug Facts
Use
to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50569-3
Ask a doctor before use if you have heart disease
Section 53414-9
May be harmful if used when pregnant or breast-feeding.
Warnings
For external use only. For use by men only.
Flammable: Keep away from fire or flame
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
Questions?
- call toll-free 800-764-2463 or 215-273-8755 (collect )
- visit www.rogaine.com
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, 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 booklet
- 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 with mostly white men aged 18-49 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 25º C (68º to 77º F)
Inactive Ingredients
alcohol, propylene glycol, purified water
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
Principal Display Panel 60 Ml Bottle Carton
#1 DERMATOLOGIST
RECOMMENDED BRAND
MEN'S
Rogaine
®
EXTRA STRENGTH
5% Minoxidil
Topical Solution
Hair Regrowth Treatment
REACTIVATES
HAIR FOLLICLES
TO STIMULATE REGROWTH
Topical Solution
CLINICALLY PROVEN TO
HELP REGROW HAIR
UNSCENTED
Not For Use By Women
One Month Supply. One 60 mL (2 fl oz) Bottle
Structured Label Content
Use
to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50569-3 (50569-3)
Ask a doctor before use if you have heart disease
Section 53414-9 (53414-9)
May be harmful if used when pregnant or breast-feeding.
Purpose
Hair regrowth treatment for men
Warnings
For external use only. For use by men only.
Flammable: Keep away from fire or flame
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
Questions?
- call toll-free 800-764-2463 or 215-273-8755 (collect )
- visit www.rogaine.com
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, 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 booklet
- 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 with mostly white men aged 18-49 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 25º C (68º to 77º F)
Inactive Ingredients (Inactive ingredients)
alcohol, propylene glycol, purified water
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
Principal Display Panel 60 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton)
#1 DERMATOLOGIST
RECOMMENDED BRAND
MEN'S
Rogaine
®
EXTRA STRENGTH
5% Minoxidil
Topical Solution
Hair Regrowth Treatment
REACTIVATES
HAIR FOLLICLES
TO STIMULATE REGROWTH
Topical Solution
CLINICALLY PROVEN TO
HELP REGROW HAIR
UNSCENTED
Not For Use By Women
One Month Supply. One 60 mL (2 fl oz) Bottle
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:10.706834 · Updated: 2026-03-14T23:04:41.766336