FDA label 5fe8669e-d1f1-42a9-8fb1-fb2efc4a6ae0

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
e5fcf842-1a6b-445a-aa50-ea1e0ffe465c
SPL ID
5fe8669e-d1f1-42a9-8fb1-fb2efc4a6ae0
Version
5
Effective date
2020-04-28
Source export date
2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:26:44

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. Avoid contact with the eyes; if contact occurs, flush with water or rub towel moistened with a fatty oil such as sesame or olive oil over closed eye and seek advice from medical personnel. If condition worsens or does not improve after regular use of product as directed, consult a doctor. Some individuals may be sensitive to tea tree or other oils. If you are pregnant or breastfeeding, ask a health professional before use. Not to be used with children under 2 years of age without physician direction. Keep all medicines out of the reach of children.

Reported adverse events (FAERS/openFDA)#

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