FDA label ec92e832-b6d1-c943-e053-2a95a90ac313

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: 4474e124-a7d7-41ce-a9ff-aac06b08f6a3
SPL ID: ec92e832-b6d1-c943-e053-2a95a90ac313
Version: 3
Effective date: 2022-11-03
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:23:28

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		ec92e832-b6d1-c943-e053-2a95a90ac313	id
spl set id		4474e124-a7d7-41ce-a9ff-aac06b08f6a3	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

Warnings For external use only Do not use this product if you or your partner are allergic (sensitive) to local anesthetics or any of the other listed ingredients. Do not use on broken or inflamed skin. When using this product avoid contact with eyes. Stop use and ask a doctor if • This product, used as directed, does not provide relief, discontinue use and consult a doctor. Premature ejaculation may be due to a condition requiring medical supervision. • You or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor. Keep out of reach of children. In case of overdose, 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.