FDA.reportPublic FDA data

Aramark Burn Spray

Manufacturer
Western First Aid Safety DBA Aramark | Safetec of America, Inc.
Effective date
2021-06-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:06

Label at a glance#

ProductAramark Burn
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Temporary pain relief for minor burns

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 2.0%

Purpose

OTC - PURPOSE SECTION

Topical pain relief

Uses

INDICATIONS & USAGE SECTION

Temporary pain relief for minor burns

WARNINGS SECTION

Warnings

For external use only

Do not use • in large quantities, particularly over raw

or blistered areas • near eyes, if this happens rinse

thoroughly with water

Stop use and ask a doctor if condition worsens or

continues for more than 7 days or clears up and returns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get

medical help or contact Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions• for adults and children 2 years of age

and older: spray an even layer of burn spray over

cleaned affected area not more than 3-4 times daily
• for children under 2 years of age consult a physician

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe vera, germaben II, propylene glycol, purified water

PRINCIPAL DISPLAY PANEL – 3 oz. bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aramark

First Aid
Burn Spray

For Temporary Pain
Relief and
Minor Burns

4 fl. oz. (118 mL)

Reorder no. 50004ARA

MANUFACTURED FOR:
Aramark
Lenexa, KS 66219 886-362-2691

5100 Burn Spray5100 Burn Spray

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010769lidocaine HCl 2 % Topical SprayPSN1
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCD1
1010769lidocaine hydrochloride 2 % 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
81238-5100-32023-01-30C16284748780-1f386c64a-416f-0266-e053-dadaa90a7c1aAramark Burn Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81238-5100-3Aramark Burn118 mL in 1 BOTTLE, SPRAYSPRAY1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81238-5100ARAMARK BURN (LIDOCAINE HCL) SPRAY [WESTERN FIRST AID SAFETY DBA ARAMARK]1Legacy NDC, 1 package rows20210629_5600b36e-788d-4bd3-9693-92eacb37eac2.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81238-510081238-5100-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALOE VERA LEAFZY81Z83H0XIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

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
700cea1b-4d2a-4e07-af1e-d65c246b3ea95600b36e-788d-4bd3-9693-92eacb37eac22021-06-28WarningsExact identifier
spl id: 700cea1b-4d2a-4e07-af1e-d65c246b3ea9
spl set id: 5600b36e-788d-4bd3-9693-92eacb37eac2

Reported adverse events (FAERS/openFDA)#

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