FDA label 5b8d0c98-1f8c-5614-e063-6394a90ae999

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
5b8d0c98-1f8c-5614-e063-6394a90ae999
Version
6
Effective date
2026-09-15
Source export date
2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:56:50

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, rinse eyes thoroughly with water. If accidental ingestion and adverse reaction occurs, get medical help or contact a Poison Control Center. Some individuals may be sensitive to essential oils Begin with a small drop to determine if product causes any irritation. Discontinue use if any irritation occurs. If condition worsens or does not improve after regular use of product as directed, consult a doctor. . 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 out of the reach of children.

Reported adverse events (FAERS/openFDA)#

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