FDA label 1834c030-1039-4889-8ae5-ac0cab201cc9

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: fd417d43-1f15-4142-a428-952b9ab05411
SPL ID: 1834c030-1039-4889-8ae5-ac0cab201cc9
Version: 2
Effective date: 2018-03-16
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:50:20

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		1834c030-1039-4889-8ae5-ac0cab201cc9	id
spl set id		fd417d43-1f15-4142-a428-952b9ab05411	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.