FDA label 60a615bb-306b-450f-944f-eb5181daa33a

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
2ff0363f-9d37-48b3-b97e-07154e04a1de
SPL ID
60a615bb-306b-450f-944f-eb5181daa33a
Version
1
Effective date
2016-12-12
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:29:44

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. Do not use on damaged skin, open wounds, or mucous membranes. • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms). • Avoid contact with the eyes. • Do not use if you are allergic to Arnica montana (Asteracea flower) or any of this product’s inactive ingredients. • Do not bandage tightly or use with a heating pad. • If conditions worsen or if symptoms persist for more than 72 hours or clear up and occur again within a few days, discontinue use of this product and consult a physician. If pregnant, trying to get pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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