FDA label 3e580f1d-f7ef-4fff-8973-cf4c8b1d3b54

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
a48b7fb3-f15c-4358-a0bb-eb4fd9c38cfd
SPL ID
3e580f1d-f7ef-4fff-8973-cf4c8b1d3b54
Version
1
Effective date
2013-12-18
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:35:17

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 As with any drug, if you are pregnant or breast-feeding, ask a health professional before use. Not for use on children under the age of 3. For external use only. Some individuals may be sensitive to essential oils, skin test for tolerability. If accidental ingestion of more then several drops and adverse reactions occurs, get medical help or contact a Poison Control Center. Do not apply to the eyes; in the event of contact, flush with water and seek advice from medical personnel. Keep all medicines out of reach of children . Stop use and consult a doctor if condition worsens, or consult a doctor if symptoms show no improvement after 6 weeks.

Reported adverse events (FAERS/openFDA)#

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