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 table
Ingredient	Strength
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VIF565UC2G	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3227bdc9-9323-68eb-e063-6294a90a29d2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
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#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82953-045	BURN GEL 01 (MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL) GEL [COSMUSES COSMETICS (NINGBO) CO., LTD.]	1	Current NDC, 1 package rows	20250408_3227bdc9-9323-68eb-e063-6294a90a29d2.zip

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.

Matched openFDA labels page 20 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Triple Antibiotic	FIRST AID TRIPLE ANTIBIOTIC	Cardinal Health 110,Inc.	844cd9a1-b68e-47d8-a5eb-c9e880ba019e	2024-01-18	Warnings	Exact identifier application number: M004
Multi-Action Antibiotic and Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE OINTMENT	Target Corporation	8fecff32-bd67-4351-90f7-0c28cb335ea3	2024-01-18	Warnings	Exact identifier application number: M004
Leader Poly Bacitracin	FIRST AID ANTIBIOTIC	Cardinal Health 110, Inc.	442e11aa-7d14-44f9-bf14-446018f1de0d	2024-01-18	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	7b16cb9b-5847-4360-9974-2118f4a2c70f	2024-01-17	Warnings	Exact identifier application number: M004
Green Guard Triple Antibiotic	BACITRACIN ZIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	bd456e2f-e6d7-d2ad-e053-2995a90a5c12	2024-01-17	Warnings	Exact identifier application number: M004
Medi-First Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	bd432abc-fefb-1b4b-e053-2995a90acb18	2024-01-17	Warnings	Exact identifier application number: M004
Crane Safety Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Crane Safety LLC	96dbc282-4b3f-aaf3-e053-2995a90a5694	2024-01-17	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Target Corporation	10c4a1b5-bb91-48da-b0ae-303e4adf793a	2024-01-17	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC	Target Corporation	6020956d-2f58-4be8-97da-3f6b7e0f34aa	2024-01-17	Warnings	Exact identifier application number: M004
Triple Antibiotic and Pain Relief	TRIPLE ANTIBIOTIC	Target Corporation	8fda7b8a-72f3-4b92-a229-ac5be0e3b3eb	2024-01-17	Warnings	Exact identifier application number: M004
Travel Savvy First Aid Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Bellegrove Medical Supply, Inc.	69fa1c9d-5e6d-4593-e053-2a91aa0a7690	2024-01-16	Warnings	Exact identifier application number: M004
American Safety First Aid Antispetic	ISOPROPYL ALCOHOL	Orazen Inc	ea302ba4-a63d-e713-e053-2995a90a3fc4	2024-01-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Sled Distribution, LLC	e7398df8-8e23-5439-e053-2a95a90ac3aa	2024-01-15	Warnings	Exact identifier application number: M004
ER Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	EVER READY FIRST AID	20f97e1c-584f-4844-afd8-8641ffe2f466	2024-01-11	Warnings	Exact identifier application number: M004
Lightning X Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	0e66af91-e0b4-827f-e063-6294a90a9847	2024-01-07	Warnings	Exact identifier application number: M004
triple antibiotic 01	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	0e1b23f3-fa1e-f42b-e063-6394a90a3bec	2024-01-04	Warnings	Exact identifier application number: M004
Triple Antibiotic Ointment, Circle K	TRIPLE ANTIBIOTIC	Lil' Drug Store products, Inc.	0d98477b-aa33-ebb7-e063-6294a90a597f	2024-01-03	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Trifecta Pharmaceuticals USA LLC	d9f2702c-a514-cb69-e053-2a95a90a29a9	2024-01-02	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	Geri-Care Pharmaceuticals, Corp	ef309620-1cf9-d007-e053-2995a90ad46f	2024-01-02	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Geri-Care Pharmaceuticals, Corp.	eec90f72-fd13-05c9-e053-2995a90a642a	2024-01-02	Warnings	Exact identifier application number: M004

Packages#

Package NDC, 11-digit format, Description table
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