FDA.reportPublic FDA data

FDA label 582ac9b2-83a1-49bb-a6eb-c6cbb81403e2

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
3fb78be2-a797-4ac1-a9aa-090d38e48fc1
SPL ID
582ac9b2-83a1-49bb-a6eb-c6cbb81403e2
Version
1
Effective date
2013-05-06
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 06:31:52

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 Stop use and ask a doctor if symptoms persist or worsen. If pregnant or breast-feeding , ask a healthcare professional before use. Keep out of reach of children . For external use only . Avoid using near eyes or mouth . In case if ingestion , seek medical attention immediately. Some individuals may be sensitive to essential oils. If irritation or reaction occurs, discontinue use. Other Information Tamper resistant for your protection. Use only if safety seal is intact.

Reported adverse events (FAERS/openFDA)#

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