FDA label fb869713-a2be-4644-bbf2-6e894ea30fef

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
b0548b21-bac7-43f1-a9ff-c4aa7b4e52b4
SPL ID
fb869713-a2be-4644-bbf2-6e894ea30fef
Version
1
Effective date
2010-07-08
Source export date
2026-09-28
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/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:51:54

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 When using this product - use only as directed - do not apply to wounds, damaged, broken or irritated skin - avoid contact with the eyes or mucous membranes - a slight burning sensation may occur upon application, but generally disappears in several days - if severe burning occurs, discontinue use - do not expose the treated area to heat or direct sunlight - do not bandage - do not use with heating pad Stop use and consult a dentist or doctor if: - condition worsens - symptoms persist for more than 7 days or clear up and occur again within a few days - redness is present - irritation develops Keep out of the reach of children. In case of overdose or allergic reaction, seek medical attention or contact a Poison Control Center right away. If pregnant or breast feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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