FDA label 4724776e-1e6d-6373-e063-6394a90a8168

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
73645780-abae-4238-b492-08d449a9453b
SPL ID
4724776e-1e6d-6373-e063-6394a90a8168
Version
2
Effective date
2025-12-29
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:31:51

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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 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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.