FDA.reportPublic FDA data

Burn ReliefRelief

Manufacturer
Dollar General | Product Quest Mfg
Effective date
2018-07-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:22

Label at a glance#

ProductBurn ReliefRelief
Active ingredientLidocaine
Label structure6 sections

Indications and uses

Temporarily relieves pain and itching due to • sunburn • minor burns • minor cuts • scrapes • insect bites • minor skin irritation

Dosage and administration

• 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: ask a doctor • to apply to face, spray into palm of hand and gently apply

Label contents#

Full prescribing information#

Active ingredient                            Purpose

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 0.5%                               External analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to

• sunburn • minor burns • minor cuts • scrapes

• insect bites • minor skin irritation

Warnings

WARNINGS SECTION

For external use only

Flammable: Do not spray while smoking or near heat or flame

SPL UNCLASSIFIED SECTION

Do not use in large quantities, particulary over raw surfaces or blistered areas.

OTC - DO NOT USE SECTION

When using this product

OTC - WHEN USING SECTION

  • keep out of your eyes
  • use only as directed
  • do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120F.

Keep out of reach of the children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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: ask a doctor

• to apply to face, spray into palm of hand and gently apply

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, 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 SprayPSN2
1442274lidocaine 5 MG/ML Topical SpraySCD2
1442274lidocaine 0.5 % Topical SpraySY2

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
55910-782-042020-01-31C16284748780-19d75b9d0-8fbc-f424-e053-dadaa90a57ceDrug Facts
55910-782-052020-01-31C16284748780-19d75b9d0-8fbc-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-782-04Burn ReliefRelief170 g in 1 CANspray1702
55910-782-05Burn ReliefRelief127 g in 1 CANspray1272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-782BURN RELIEFRELIEF (LIDOCAINE 0.5%) SPRAY [DOLLAR GENERAL]2Legacy NDC, 2 package rows20180720_400ece63-e774-4638-9208-a1935ec302ed.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
55910-78255910-782-05, 55910-782-04

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 · 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
87cfd9e8-f2b6-4dd6-822d-837b0c5df158400ece63-e774-4638-9208-a1935ec302ed2018-07-20WarningsExact identifier
spl id: 87cfd9e8-f2b6-4dd6-822d-837b0c5df158
spl set id: 400ece63-e774-4638-9208-a1935ec302ed

Reported adverse events (FAERS/openFDA)#

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