FDA label bb1112b1-36e6-4cd5-8aa7-9fb7fc2d363e

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
d35e3a8a-d0ca-4848-ae5c-6b9f20dc2d5e
SPL ID
bb1112b1-36e6-4cd5-8aa7-9fb7fc2d363e
Version
4
Effective date
2017-01-24
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:27

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 Traumeel Tablets: If symptoms persist or worsen, a healthcare provider should be consulted. Do not use if known sensitivity to Traumeel® or any of its ingredients exists. Keep out of reach of children. If pregnant or breast-feeding, ask a healthcare provider before use. Traumeel Ointment: For external use only. Do not apply over open wounds or broken skin. If symptoms persist or worsen, or if a rash develops, a healthcare provider should be consulted. In rare cases, allergic skin reactions may develop. Do not use if known sensitivity to Traumeel® or any of its ingredients exists. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a healthcare provider before use.

Reported adverse events (FAERS/openFDA)#

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