FDA.reportPublic FDA data

FDA label 08d6435d-dad7-4245-b954-a0a075ef6869

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
c008682c-f963-40c2-ab37-25b012f02be8
SPL ID
08d6435d-dad7-4245-b954-a0a075ef6869
Version
1
Effective date
2016-06-24
Source export date
2026-08-08
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/1742e81476d3d6cada20c9e3894391dc6e407b1d0da716d0da13f6f74451bfd1/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:58:52

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. Avoid contact with eyes Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a doctor. If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. if symptoms persist, consult a doctor.