FDA label ec13cadd-84f7-49bf-af16-ffc2f6a8f731

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
acba12e6-0e9c-4f15-92b3-07ca2f9c7622
SPL ID
ec13cadd-84f7-49bf-af16-ffc2f6a8f731
Version
1
Effective date
2013-04-09
Source export date
2026-11-06
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/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:05:52

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 For external use only Allergy alert: allergic skin reactions or contact dermatitis are possible. Do not use if hypersensitive to plants of the Anacardiaceae family if hypersensitive to arnica or rosemary during pregnancy in patients with bronchial asthma or whooping cough in children under the age of 5 years in the area of the breasts when breastfeeding When using this product skin and mucous membrane irritation may occur bronchospasms may be intensified avoid contact with eyes do not apply the ointment in the area on the face, particularly the nose apply only to intact, uninjured skin do not apply to mucous membranes the application of external heat may result in excessive irritation or burning. Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days irritation occurs. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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