FDA label b444c82c-6d45-4e5c-856a-8676a321d59e

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
0871d193-e6c4-7c88-e063-6294a90a3b2f
SPL ID
b444c82c-6d45-4e5c-856a-8676a321d59e
Version
3
Effective date
2023-11-03
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:21

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. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application. Do not use if • you have no family history of hair loss • 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. • scalp is red, inflamed, infected, irritated, or painful • you use other medicines on the scalp When using this product • Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. • It takes time to regrow hair. You may need to use this product 2 times a day 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 everyone. Stop use and ask a doctor if • chest pain, rapid heart beat, faintness, or dizziness occurs • sudden, unexplained weight gain occurs • your hands or feet swell • scalp irritation or redness occurs • you get unwanted facial hair growth • you do not see hair regrowth in 4 months 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.