FDA.reportPublic FDA data

FDA label 629af246-2126-4343-e053-2a91aa0a0d71

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
ed0e30d0-e4e9-482b-99db-d6341bc720ab
SPL ID
629af246-2126-4343-e053-2a91aa0a0d71
Version
2
Effective date
2018-01-12
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:34:39

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: 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. • For topical use only. • Do not use if you or your partner are allergic to Lidocaine or topical anesthetics. • Keep away from fire and flame. • Discontinue use if you or your partner develop a rash or irritation, such as burning or Itching. • Do not spray on broken, irritated or sensitive skin. • Avoid contact with eyes. • For external use only.

Reported adverse events (FAERS/openFDA)#

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