burn gel
- Product NDC
- 82953-045
- 11-digit product format
- 829530045
- Labeler code
- 82953
- Product ID
- 82953-045_3227b643-a99e-6716-e063-6294a90a73b7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- melaleuca alternifolia (tea tree) leaf oil
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Cosmuses Cosmetics (Ningbo) Co., Ltd.
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-06
- Substance
- MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
- Active strength
- 1 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- burn gel
- Brand name suffix
- 01
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL | 1 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VIF565UC2G | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3227bdc9-9323-68eb-e063-6294a90a29d2 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82953-045-01 | burn gel01 | 0.85 g in 1 POUCH | GEL | 0.85 | 1 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Balma Septic Antiseptic Hand Wash | BENZALKONIUM CHLORIDE | Rochester Midland Corporation | 1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528 | 2025-01-10 | Warnings | M004 |
| LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380 | CHLOROXYLENOL | ABC Compounding Co., Inc. | efa3938f-64de-77ba-e053-2a95a90ac840 | 2025-01-10 | Warnings | M004 |
| Bacitracin | BACITRACIN | A-S Medication Solutions | 64aa660d-2d69-48e8-bd0d-4876815d89ff | 2025-01-08 | Warnings | M004 |
| Bacitracin | BACITRACIN | Water-Jel Technologies | 412928a1-3708-4fa8-99c5-aaa2b079cf6e | 2025-01-06 | Warnings | M004 |
| AVON HeXashield Triple Antibiotic with Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL | Tai Guk Pharm. Co., Ltd. | 8e0cb861-d8aa-1f71-e053-2a95a90aaa88 | 2025-01-01 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Trifecta Pharmaceuticals USA LLC | 087694c2-4b1b-e293-e063-6294a90a961f | 2024-12-31 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE | TRIFECTA PHARMACEUTICALS USA LLC | 0c017b10-29b6-e30f-e063-6294a90a8a3c | 2024-12-31 | Warnings | M004 |
| Triple Antibiotic and Pain Relief | BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE | Trifecta Pharmaceutical USA LLC | 0bf08cf6-be3f-f9aa-e063-6294a90a4393 | 2024-12-31 | Warnings | M004 |
| Single Antibiotic with Bacitracin | BACITRACIN ZINC | Randob Labs Ltd. | 2a807f1b-986f-a9ea-e063-6394a90aed25 | 2024-12-30 | Warnings | M004 |
| Tripleantibioticapainscaritch | FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCL | Trifecta Pharmaceutical USA LLC | 935106c6-8a9e-07fa-e053-2a95a90a2484 | 2024-12-20 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | TRIFECTA PHARMACEUTICALS USA LLC | 00c52a31-9bfa-a8bf-e063-6294a90ac4d7 | 2024-12-20 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE | Trifecta Pharmaceuticals Usa Llc | d04b397c-1608-4fd9-be28-ef7285d6a996 | 2024-12-20 | Warnings | M004 |
| Tripleantibioticointmentandpainrelief | FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE | Trifecta Pharmaceutical USA LLC | 91575333-5268-5d8f-e053-2a95a90a7a89 | 2024-12-20 | Warnings | M004 |
| Premier Value Max Strength Antibiotic plus pain relief | PREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL | Pharmacy Value Alliance LLC | 9767821e-054b-3bd3-e053-2a95a90a4b0e | 2024-12-20 | Warnings | M004 |
| Premier Value Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Premier Value Alliance LLC. | ab843664-a1e0-6716-e053-2995a90a2063 | 2024-12-20 | Warnings | M004 |
| Premier Value Bacitracin Zinc | BACITRACIN ZINC | Pharmacy Value Alliance LLC | 99d789be-aa85-0917-e053-2a95a90acd13 | 2024-12-20 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Premier Value Alliance LLC. | ab863d90-1a8f-3c1f-e053-2a95a90aa0a7 | 2024-12-20 | Warnings | M004 |
| Family Wellness First Aid Antibiotic | FAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATE | Trifecta Pharmaceuticals USA, LLC | 9157681a-3ed1-096e-e053-2a95a90a05e3 | 2024-12-18 | Warnings | M004 |
| Family Wellness Original | FAMILY WELLNESS BACITRACIN, NEOMYCIN, POLYMYXIN B | Trifecta Pharmaceuticals USA LLC. | 915759af-0d4f-6a87-e053-2a95a90acbd6 | 2024-12-18 | Warnings | M004 |
| Family Wellness Pain Scar Itch | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL | Trifecta Pharmaceutical USA LLC | 9e507ec5-310d-3a21-e053-2a95a90a15a6 | 2024-12-18 | Warnings | M004 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 82953-045-01 | 82953004501 | .85 g in 1 POUCH (82953-045-01) | 2025-04-06 | No | No | Current |