FDA.reportPublic FDA data

Burn Spray

Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Effective date
2024-07-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:15:12

Label at a glance#

ProductBurn Relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure13 sections

Dosage and administration

Spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily. Not to be used on children under 12 years of age.

Storage and handling

Store at controlled room temperature 68º-77ºF (20º-25ºC)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 2.0%

Purpose

OTC - PURPOSE SECTION

Topical Pain Relief

INDICATIONS & USAGE SECTION

Temporary pain relief associated with minor burns.

Warnings

WARNINGS SECTION

For External Use Only

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If the condition worsens or persists for more than 7 days or clears up and returns.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

OTC - DO NOT USE SECTION

  • In large quantities, particularly over raw or blistered areas
  • Near eyes, if this happens rinse throughly with water

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily.
  • Not to be used on children under 12 years of age.

Other information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 68º-77ºF (20º-25ºC)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, hydroxypropyl methylcellulose, melaleuca alternifilia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol propylene glycol, triethanolamine, water

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Distributed By:

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 4049

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4049 GLOBE BURN SPRAY 2OZ REV09 071024 CDER4049 GLOBE BURN SPRAY 2OZ REV09 071024 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010769lidocaine HCl 2 % Topical SprayPSN4
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCD4
1010769lidocaine hydrochloride 2 % Topical SpraySY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-107-02Burn Relief0.0591 L in 1 BOTTLE, SPRAYSPRAY0.05914

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-107BURN RELIEF (LIDOCAINE HCI 2.0%) SPRAY [TRIFECTA PHARMACEUTICALS USA, LLC.]4Current NDC, Legacy NDC, 1 package rows20240713_e5e524cd-bb22-715f-e053-2995a90ab5d3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-10769396-107-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
GLYCERINPDC6A3C0OXIACT
TEA TREE OILVIF565UC2GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
OCTOXYNOL-97JPC6Y25QSIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYPROMELLOSES3NXW29V3WOIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn ReliefLIDOCAINE HCI 2.0%Trifecta Pharmaceuticals USA, LLC.e5e524cd-bb22-715f-e053-2995a90ab5d32024-07-12WarningsExact identifier
ndc (package): 69396-107-02
ndc (product): 69396-107
ndc11 (package): 69396010702
spl id: 1d0cada6-0c76-81d5-e063-6394a90ad666
spl set id: e5e524cd-bb22-715f-e053-2995a90ab5d3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.