FDA.reportPublic FDA data

Aramark Burn Gel

Manufacturer
Western First Aid Safety DBA Aramark | Safetec of America, Inc.
Effective date
2021-09-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:42:20

Label at a glance#

ProductAramark Burn Gel
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

Temporary pain relief for minor burns. For professional use only.

Dosage and administration

• 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: do not use, consult a doctor

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. For

professional use only.

Warnings

WARNINGS SECTION

For external use only.

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 directly.

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - STOP USE SECTION

• the condition worsens or symptoms persist for more

than 7 days or clear up and occur again within a few days

Directions

DOSAGE & ADMINISTRATION SECTION

• 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: do not use, consult a doctor

Other Information

OTHER SAFETY INFORMATION

• store at room temperature (do not freeze)

• do not use any open or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, carbomer, germaben II, menthol,

propylene glycol, purified water, triethanolamine,

vitamin E acetate

Questions od Comments?

OTC - QUESTIONS SECTION

1-800-456-7077

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aramark

25 ct. Each Packet Net. Wt. 0.9g

BURN GEL
For Temporary Pain Relief of Minor Burns

aramarkuniform.com

MANUFACTURED FOR:
Aramark
Lenexa, KS 66219 

886-362-2691

Please retain carton for drug information.

5000-5 Burn Gel Box5000-5 Burn Gel Box

5000-5 Burn Gel Pouch5000-5 Burn Gel Pouch

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011852lidocaine HCl 2 % Topical GelPSN3
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD3
1011852lidocaine hydrochloride 2 % Topical JellySY3

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
81238-5000-52023-01-30C16284748780-1f386c649-ba4f-0266-e053-dadaa90a7c1aaramark Burn Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81238-5000-5Aramark Burn Gel25 in 1 BOXGEL253
81238-5000-5Aramark Burn Gel1 g in 1 POUCHGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81238-5000ARAMARK BURN GEL (LIDOCAINE) GEL [WESTERN FIRST AID SAFETY DBA ARAMARK]3Legacy NDC, 2 package rows20210911_456d51a1-2d16-4f5f-a6b0-b160819f1227.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81238-500081238-5000-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
MENTHOLL7T10EIP3AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
889dbc6f-2603-4fff-acea-c3479a139f1d456d51a1-2d16-4f5f-a6b0-b160819f12272021-09-09WarningsExact identifier
spl id: 889dbc6f-2603-4fff-acea-c3479a139f1d
spl set id: 456d51a1-2d16-4f5f-a6b0-b160819f1227

Reported adverse events (FAERS/openFDA)#

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