FDA label 089852c9-4482-45d0-a85d-d4fa7d0a79fe

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
afd92705-bd32-48f6-a322-7f44df41b973
SPL ID
089852c9-4482-45d0-a85d-d4fa7d0a79fe
Version
1
Effective date
2014-01-02
Source export date
2026-09-28
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/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:32:36

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 and seek advice from medical personnel. If condition worsens or does not improve after regular use of product as directed, consult a doctor. Do not apply to wounds or damaged skin, use for prolonged periods, or use over raw surfaces or blistered areas without consulting 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.