FDA label 55480e63-4b5c-4230-905b-5edfc1f7bb18

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: 0584e235-34f8-4d53-aa7c-ac11e01ac456
SPL ID: 55480e63-4b5c-4230-905b-5edfc1f7bb18
Version: 2
Effective date: 2012-05-08
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 02:06:58

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		55480e63-4b5c-4230-905b-5edfc1f7bb18	id
spl set id		0584e235-34f8-4d53-aa7c-ac11e01ac456	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 Consult a physician or qualified health care professional prior to using this product if you have any medical conditions, or if you are using any prescription drug. Allergy alert do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. KEEP OUT OF REACH OF CHILDREN. This carrying case may present a choking hazard. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away. Stop use and ask doctor if swelling, rash or fever develops irritation, pain or redness persists or worsens symptoms do not improve in 7 days

Reported adverse events (FAERS/openFDA)#

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