Burn Relief

Manufacturer
Amerisource Bergen | Product Quest Mfg
Effective date
2018-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:23

Label at a glance#

ProductBurn Relief
Active ingredientLidocaine
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                     Purpose
Lidocaine 0.5%.........................External analgesic

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of pain and itching associated with: • sunburn
• minor burns • minor cuts • scrapes • insect bites • minor skin irritations

WARNINGS SECTION

Warnings
For external use only.
Flammable: Do not use near heat, flame, or while smoking.
Do not use in large quantities, particularly over raw surfaces or blistered areas.
When using this product • keep away from face to avoid breathing it. • avoid
contact with eyes. • use only as directed. • do not puncture or incinerate.
Contents under pressure. Do not store at temperatures above 120ºF.
If condition worsens or if symptoms persist for more than 7 days or clear up and
occur again within a few days, discontinue use of this product and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions • Shake well • Adults and children 2 years of age and older: apply
to affected area not more than 3 to 4 times daily • Children under 2 years of age:
consult a doctor • Do not spray directly into face; spray into palm of hand and
gently apply

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aloe Barbadensis Leaf Extract, Carbomer, Diazolidinyl
Urea, Disodium Cocoamphodipropionate, Disodium EDTA, Glycerin, Methylparaben,
Propylene Glycol, Propylparaben, SD Alcohol 40, Simethicone, Tocopheryl Acetate,
Triethanolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1442274lidocaine 0.5 % Topical SprayPSN1
1442274lidocaine 5 MG/ML Topical SpraySCD1
1442274lidocaine 0.5 % Topical SpraySY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24385-777-042020-01-31C16284748780-19d75b9d0-3712-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24385-777-04Burn Relief128 g in 1 CANSPRAY1281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24385-777BURN RELIEF (LIDOCAINE) SPRAY [AMERISOURCE BERGEN]1Legacy NDC, 1 package rows20180723_77072d8c-080d-4a3d-8733-ea25aee765cf.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
24385-77724385-777-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML · Source PDF

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
be6f2378-cd98-4278-8f02-9092a99306f577072d8c-080d-4a3d-8733-ea25aee765cf2018-07-23WarningsExact identifier
spl id: be6f2378-cd98-4278-8f02-9092a99306f5
spl set id: 77072d8c-080d-4a3d-8733-ea25aee765cf

Reported adverse events (FAERS/openFDA)#

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