Regoxidine

Minoxidil · Aerosol, Foam · Topical

Over the counter Arteriolar Vasodilator

Active ingredient

Active ingredient Minoxidil 5% w/w (without propellant)

Purpose

Purpose Hair regrowth treatment for men

Uses

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

Warnings

Warnings For external use only. For use by men only. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application. Do not use if you are a woman your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam 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 Ask a doctor before use if you have heart disease 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 May be harmful if used when pregnant or breast-feeding. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do not use

Do not use if you are a woman your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam 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

Ask a doctor before use

Ask a doctor before use if you have heart disease

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

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

Pregnancy or breast-feeding

May be harmful if used when pregnant or breast-feeding.

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).

Directions

Directions apply half a capful 2 times a day to the scalp in the hair loss area massage into scalp with fingers, then wash hands well see enclosed leaflet for complete directions on how to use 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

Other information

Other information hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months 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. store at controlled room temperature 20° to 25°C (68° to 77°F) contents under pressure. Do not puncture or incinerate container. do not expose to heat or store at temperatures above 120°F (49°C).

Inactive ingredients

Inactive ingredients butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol

Questions?

Questions? Call 1-866-923-4914

Label text from the FDA structured product label by Innovus Pharmaceuticals, Inc. (revised Dec 16, 2022). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Regoxidine NDC products (2)

NDCStrength & formLabelerType
57483-530Minoxidil 50 mg/g
Aerosol, Foam
Innovus Pharmaceuticals, Inc.ANDA
57483-540Minoxidil 50 mg/g
Aerosol, Foam
Innovus Pharmaceuticals, Inc.ANDA

Frequently asked questions

What is Regoxidine used for?

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

Who makes Regoxidine?

Regoxidine is listed by 1 labeler in the FDA NDC directory, including Innovus Pharmaceuticals, Inc..