FDA label 8aa9d1c8-3a8b-4900-8498-5937fad97fa1

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
a273e461-20e0-44f2-e053-2a95a90aa9c6
SPL ID
8aa9d1c8-3a8b-4900-8498-5937fad97fa1
Version
4
Effective date
2022-11-17
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 02:51:17

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

For external use only when using this product • If the following abnormal symptoms persist, discontinue use irritation around the eyes, ears, mucous membranes, including the mouth, irritation or rashes on the skin. • Stop use immediately and consult a doctor if you experience the following : 1) Hypersensitivity symptoms such as erythema, itching and dermatitis. 2) Skin irritation 3) Follow instructions when using medication. (1) For external use only (Do not use internally) (2) Avoid getting into the eyes (If contact occurs, rinse thoroughly with clean water) • Be careful not to inhale or use for extended periods of time (inhalation of ethanol repeatedly can cause irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly on the same area, skin irritation may occur. • Do not use the product on the same areas for extended periods of time as swelling, inflammation or sickness may occur due to absorption through the skin. It is not recommended to use on areas with open wounds that have been medically treated with a cast or bandage. • Do not use in combination with soap or antibacterial cleansing agents.

Reported adverse events (FAERS/openFDA)#

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