warnings and cautions
WARNINGS AND PRECAUTIONS None
FDA label 481ac8c7-8ec2-40e1-b29a-e846a24ad4a2
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
- 8e4a234c-785f-4be0-9a11-50bd82e2311e
- SPL ID
- 481ac8c7-8ec2-40e1-b29a-e846a24ad4a2
- Version
- 15
- Effective date
- 2021-10-14
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:45:13
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 | 481ac8c7-8ec2-40e1-b29a-e846a24ad4a2 | id | |
| spl set id | 8e4a234c-785f-4be0-9a11-50bd82e2311e | 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
ADVERSERE REACTIONS Post-marketing Experience • The following adverse events have been identified during post-marketing use of Zeel ® 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 Zeel ® Injection Solution: Allergic (hypersensitivity) skin reactions may occur in isolated cases. •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. 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.