FDA.reportPublic FDA data

Burn Relief

Manufacturer
Better Living | Product Quest Mfg
Effective date
2018-01-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:03

Label at a glance#

ProductBurn Relief Signature Care
Active ingredientLidocaine
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                                           Purpose
Lidocaine 0.5%.............................................................Topical anesthetic

INDICATIONS & USAGE SECTION

Uses
For temporary relief of pain associated with pain or itching due to : minor burns, sunburns, minor cuts, insect bites, skin irritation

WARNINGS SECTION

Warnings
For external use only.

Flammable: Do not use while smoking or near heat or flame
When using this product • use only as directed • avoid contact with eyes

Do not puncture or incenerate. Contents under pressure. Do not store at temperature above 120F
Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within
a few days.

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 immediately

DOSAGE & ADMINISTRATION SECTION

Directions
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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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 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
21130-761-042020-01-31C16284748780-19d75b9d0-1078-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-761-04Burn ReliefSignature Care127 g in 1 CANSPRAY1271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-761BURN RELIEF SIGNATURE CARE (LIDOCAINE 0.50%) SPRAY [BETTER LIVING]1Legacy NDC, 1 package rows20180330_399e7f75-4fd6-4515-84f2-f0e24b2984b9.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
21130-76121130-761-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Lidocaine98PI200987ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
Diazolidinyl UreaH5RIZ3MPW4IACT
Disodium Cocoamphodipropionate6K8PRP397MIACT
EDETATE DISODIUM7FLD91C86KIACT
GlycerinPDC6A3C0OXIACT
MethylparabenA2I8C7HI9TIACT
Propylene Glycol6DC9Q167V3IACT
PropylparabenZ8IX2SC1OHIACT
Alcohol3K9958V90MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT

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
69211494-092e-4f25-9b90-937ab2794b6d399e7f75-4fd6-4515-84f2-f0e24b2984b92018-01-19WarningsExact identifier
spl id: 69211494-092e-4f25-9b90-937ab2794b6d
spl set id: 399e7f75-4fd6-4515-84f2-f0e24b2984b9

Reported adverse events (FAERS/openFDA)#

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