FDA label 48f0d7a5-575f-4fa5-8358-6ce511ae61b5

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
d4a31874-e479-453f-aef4-ad43b2c1ab01
SPL ID
48f0d7a5-575f-4fa5-8358-6ce511ae61b5
Version
1
Effective date
2013-10-01
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:02:21

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 breast-feeding, 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.