FDA label 748423fe-34f7-4321-8adb-723fbb9730a0

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: 65927deb-bb6c-4e9c-b0af-3da6f5ad85a7
SPL ID: 748423fe-34f7-4321-8adb-723fbb9730a0
Version: 4
Effective date: 2018-03-25
Source export date: 2026-10-12
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:08:09

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		748423fe-34f7-4321-8adb-723fbb9730a0	id
spl set id		65927deb-bb6c-4e9c-b0af-3da6f5ad85a7	set_id

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

WARNING: For External Use Only. Do Not Use: • on broken or inflamed skin • if partner is pregnant • on large areas of the body and/or orally When Using This Product Apply to Penile Area Only Avoid Contact with Eyes. If Irritation Occurs, Discontinue Use Do Not Use More Than Directed Stop use and consult a doctor • If you or your partner develop a rash or irritation such as burning or itching • If this product, used as directed, does not provide relief. Premature Ejaculation may be due to a condition requiring medical supervision.

Reported adverse events (FAERS/openFDA)#

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