FDA label 3525ff6e-0a3c-443d-8729-8d36399fd70c

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
7c2c9d1c-8595-4245-b567-e49158da448e
SPL ID
3525ff6e-0a3c-443d-8729-8d36399fd70c
Version
1
Effective date
2014-05-06
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:47:25

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 inside of this insert or your hair loss is on the front of the scalp. Minoxidil Topical Solution, 5% 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, 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: Side effects occur: You may report side effects to FDA at 1-800-FDA-1088 or to Toppik Inc. at 1-800-THICKEN (844-2536). 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 If pregnant or breast-feeding, ask a health professional before use. 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.