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 22 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Wellness Antiseptic and Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	FRONT PHARMACEUTICAL PLC	cb7fdcde-2bd8-4834-ba4e-4d6fd1512599	2023-10-26	Warnings	Exact identifier application number: M004
GENUINE FIRST AID Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	23abfe12-5b50-4b49-878e-4fcdb6c341fd	2023-10-19	Warnings	Exact identifier application number: M004
EVERLIT CARE Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	f4921508-c32f-426f-a2f0-16c3acbd4713	2023-10-14	Warnings	Exact identifier application number: M004
Cuadriderma	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE	ProMex LLC	4fa99b96-ab4b-4523-82bc-343dbaf39fb6	2022-01-25	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