FDA.reportPublic FDA data

Afassco First Aid Burn Cream

Manufacturer
Afassco Inc.
Effective date
2019-01-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:10

Label at a glance#

ProductAfassco First Aid Burn Cream
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Benzalkonium Chloride  0.13%
Lidocaine HCL   0.5%

OTC - PURPOSE SECTION

Purpose  First aid antiseptic., external amalgesic

INDICATIONS & USAGE SECTION

Uses

first aid to help prevent
infection and for the
temporary relief of pain and
itching associated with minor
cuts, scrapes, burns

WARNINGS SECTION

Warnings

For external use only

Do not use ■ in eyes ■ in

large quantities, over raw

blistered areas, on deep

puncture wounds, animal

bites or serious burns ■ for

more than one wek

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

a small amount on area, not

more than 3 times daily

■ may cover with a sterile bandage

OTHER SAFETY INFORMATION

Other Information

store at room temperature

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Peregal-O 2.5%, Glycerin

Monostearate 2.5%, Glycerol

5%, Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

↓Principal Display 6 ct. Package↓

Afassco¦ ¦®

The First Choice

in First Aid

FIRST AID/BURN CREAM

No.339              6 ct.

6 ct.

FIRST AID/
BURN CREAM

ANSI Z308.1

Manufactured for Afassco, Inc., Minden, NV 89423

6 70254 20339 9

First Aid Burn Crm Box 6ctFirst Aid Burn Crm Box 6ct

↓Principal Display 25 ct. Package↓

First Aid Burn Crm Box 25ctFirst Aid Burn Crm Box 25ct

↓1 gm Packet↓

First Aid Burn Crm 1gmFirst Aid Burn Crm 1gm

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN1
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD1
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY1

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
51532-4622-12023-01-30C16284748780-1f386c649-e637-0266-e053-dadaa90a7c1aAfassco First Aid Burn Cream
51532-4622-22023-01-30C16284748780-1f386c649-e637-0266-e053-dadaa90a7c1aAfassco First Aid Burn Cream

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51532-4622AFASSCO FIRST AID BURN CREAM (LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE) OINTMENT [AFASSCO INC.]1Legacy NDC20190111_6e116699-0640-4415-975c-2df53d6e06ac.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
51532-462251532-4622-1, 51532-4622-2

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
4f975b29-8d84-4cd1-80bb-c994cb2c8ed96e116699-0640-4415-975c-2df53d6e06ac2019-01-09WarningsExact identifier
spl id: 4f975b29-8d84-4cd1-80bb-c994cb2c8ed9
spl set id: 6e116699-0640-4415-975c-2df53d6e06ac

Reported adverse events (FAERS/openFDA)#

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