Nuvari
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Minoxidil (Topical) Side Effects, Dosing and Safety

Important Safety Information

CROWN Protocol

Warnings and Precautions

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

Full prescribing information

Transcribed word for word from the FDA label for Mens Rogaine Extra Strength Unscented (minoxidil, topical), effective September 6, 2024. Source details

Indications

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

Use in Specific Populations

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

Source

Every clinical sentence on this page is transcribed word for word from the U.S. FDA prescribing information for the product below. Nothing is summarised or rewritten. Sections describing the approved product's dosage forms, administration devices, packaging and storage are not included, because Nuvari dispenses a compounded formulation.

FDA label
Mens Rogaine Extra Strength Unscented (minoxidil, topical)
Label effective date
September 6, 2024
Retrieved
August 16, 2026
SPL set id
ccaecec5-5348-4b24-9190-5464c50f6d80
Source system
openFDA drug/label (api.fda.gov) — U.S. FDA structured product labeling
Read the full label
DailyMed, U.S. National Library of Medicine