FDA.reportPublic FDA data

Aramark Burn Cream

Manufacturer
Western First Aid Safety dba Aramark | Safetec of America, Inc.
Effective date
2021-05-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:29

Label at a glance#

ProductAramark Burn Cream
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Benzalkonium Chloride 0.13%
Antiseptic Lidocaine HCI0.5%

OTC - PURPOSE SECTION

Purpose
Benzalkonium Chloride ......First Aid Antiseptic

Lidocaine HCl .................Topical Analgesic

INDICATIONS & USAGE SECTION

Uses:
• Temporary relief of pain associated with minor cuts, scrapes,
   and burns
• Helps protect against harmful bacteria

WARNINGS SECTION

Warnings: For External Use Only
Do not use:
• in eyes • in large quantities • over raw or blistered areas, or on
deep puncture wounds,
animal bites, or serious burns • for more than one week unless
directed by a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If ingested, contact a Poison
Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:
• clean affected area • apply small amount not more than 3 times
  daily
• may be covered with a sterile bandage

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Peregal-O, Glycerin Monostearate,
Glycerol, Purified Water

Product Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aramark

25 ct. of 1g packets

FIRST AID/
BURN CREAM

ANTISEPTIC•ANESTHETIC

RELIEVES PAIN • SOOTHES • PROTECTS
AGAINST INFECTION

Retain carton for complete product information

REMOVE TOP FOR
EASY ACCESS

ANTISEPTIC•ANESTHETIC

compares to
J&J First
Aid Cream

RELIEVES PAIN•SOOTHES•
PROTECTS AGAINST INFECTION

aramarkuniform.com

MANUFACTURED BY:
Aramark
Lenexa, KS 66219 (913) 269-9611

4622 25 Ct Box4622 25 Ct Box

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN2
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD2
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY2

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
81238-4622-22023-01-30C16284748780-1f386c649-a77e-0266-e053-dadaa90a7c1aaramark Burn Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81238-4622-2Aramark Burn Cream1 g in 1 POUCHCREAM12
81238-4622-2Aramark Burn Cream25 in 1 BOXCREAM252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81238-4622ARAMARK BURN CREAM (LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE) CREAM [WESTERN FIRST AID SAFETY DBA ARAMARK]2Legacy NDC, 2 package rows20210522_a0c7cea6-18e8-4b46-8307-388fc3798c34.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81238-462281238-4622-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
DIGLYCERIN MONOSTEARATEE3XK1VOF1YIACT
GLYCERINPDC6A3C0OXIACT
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
c2917429-7614-444a-b345-cefb7be86f63a0c7cea6-18e8-4b46-8307-388fc3798c342021-05-21WarningsExact identifier
spl id: c2917429-7614-444a-b345-cefb7be86f63
spl set id: a0c7cea6-18e8-4b46-8307-388fc3798c34

Reported adverse events (FAERS/openFDA)#

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