FDA label 9c0fe309-ff5a-47fa-8e56-343988465ce8

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
04d75d66-8c69-4bf3-9872-ca37d86b244a
SPL ID
9c0fe309-ff5a-47fa-8e56-343988465ce8
Version
1
Effective date
2010-08-23
Source export date
2026-11-06
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/2026-11-06/5731a8c92e1c0dd2a09d2f92b410e7a70ea29cbf6b8040a6a05e4be5b7c51f0d/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:40:43

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 symptoms of pain and swelling 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. If you are pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. If accidental ingestion, get medical help or contact a Poison Control Center. For external use only. Do not apply to the eyes or mucous membranes. Keep all medicines out of the reach of children. Stop use and ask a doctor if condition worsens or symptoms last more than 7 days.

Reported adverse events (FAERS/openFDA)#

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