warnings
Warnings For external Use Only Do not use in eyes in large quantities over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns for more than one week unless directed by a doctor
Burn Cream
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
- Brand name
- Burn Cream
- Generic name
- BENZALKONIUM CHLORIDE, LIDOCAINE HCI
- Manufacturer
- Trifecta Pharmaceuticals USA LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- fe439c60-5a02-648f-e053-6294a90a1403
- SPL ID
- 3d0f0b60-9ea4-700a-e063-6294a90a0d27
- Version
- 4
- Effective date
- 2025-08-23
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:15:20
| Harmonized routes |
|---|
| TOPICAL |
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 |
|---|---|---|---|
| application number | M003 | openfda.application_number | |
| brand name | Burn Cream | openfda.brand_name | |
| generic name | BENZALKONIUM CHLORIDE, LIDOCAINE HCI | openfda.generic_name | |
| manufacturer name | Trifecta Pharmaceuticals USA LLC | openfda.manufacturer_name | |
| ndc | package | 69396-124-09 | openfda.package_ndc |
| ndc | product | 69396-124 | openfda.product_ndc |
| ndc11 | package | 69396012409 | derived:openfda.package_ndc |
| rxcui | 1012100 | openfda.rxcui | |
| spl id | 3d0f0b60-9ea4-700a-e063-6294a90a0d27 | id | |
| spl set id | fe439c60-5a02-648f-e053-6294a90a1403 | set_id | |
| unii | F5UM2KM3W7 | openfda.unii | |
| unii | V13007Z41A | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.