FDA label 165baf68-b46c-4ef3-a9ba-9b765c1ac211

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
8c822956-fc1c-4dd4-b305-5cca96def18e
SPL ID
165baf68-b46c-4ef3-a9ba-9b765c1ac211
Version
1
Effective date
2010-08-24
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:22:24

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 If skin symptoms worsen consult a health care professional. Some individuals may be sensitive to tea tree or other oils. Begin with a small drop to determine if the product causes any increased redness or irritation and discontinue use if it irritates your skin. As with all medication, if you are pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. For external use only. If accidental ingestion of more than a few drops, or an adverse reaction occurs, seek medical help. Do not apply to the eyes. Keep all medicines out of the reach of children. Stop use and ask a doctor if condition worsens.

Reported adverse events (FAERS/openFDA)#

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