warnings and cautions
WARNINGS AND PRECAUTIONS None
FDA label 11e7b387-3044-4f7f-b3e7-2938cae3d0b2
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
- SPL set ID
- 8fe6a726-ee74-4cb8-8240-2d91a3868749
- SPL ID
- 11e7b387-3044-4f7f-b3e7-2938cae3d0b2
- Version
- 14
- Effective date
- 2021-10-14
- Source export date
- 2026-10-12
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:46:33
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 11e7b387-3044-4f7f-b3e7-2938cae3d0b2 | id | |
| spl set id | 8fe6a726-ee74-4cb8-8240-2d91a3868749 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Post-marketing Experience • The following adverse events have been identified during post-marketing use of Traumeel ® Injection Solution. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Adverse event rates observed in Monotherapy use of Traumeel ® Injection Solution: Allergic (hypersensitivity) reactions (e.g. skin allergies, redness/swelling at the injection site, even up to anaphylaxis) may occur in isolated cases. • Adverse event rates observed in the Monotherapy use of Zeel ® Injection Solution: Allergic (hypersensitivity) skin reactions may occur in isolated cases. •To report SUSPECTED ADVERSE REACTIONS, contact MediNatura at 1.844.633.4628 or info@medinatura.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.