FDA label d91f4d8f-934f-45b0-805b-222315802381

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
8b292cc5-c9ec-44ab-8c08-ba153a58d9fd
SPL ID
d91f4d8f-934f-45b0-805b-222315802381
Version
5
Effective date
2021-04-16
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:40:58

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 Allergy alert This product may cause a severe allergic reaction. Symptoms may include: • hives • facial swelling • wheezing/difficulty breathing • shock • rash If an allergic reaction occurs, stop use and seek medical help right away. For external use only Do not use • if you are allergic to any ingredient in this product When using this product • apply only to affected areas • do not use in or near the eyes • avoid applying directly inside your mouth • do not share this product with anyone. This may spread infection. Stop use and ask a doctor if • your cold sore gets worse or the cold sore is not healed within 10 days Keep out of reach of children. If swallowed, 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.