FDA.reportPublic FDA data

First Aid Only First Aid-Burn Cream

Manufacturer
Acme United Corporation
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:45:08

Label at a glance#

ProductFirst Aid Only First Aid-Burn
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

clean affected area apply small amount 1-3 times daily children under 2 : consult doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

External Analgesic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor

  • cuts
  • scrapes
  • burns.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body
  • in large quantities, particularly over raw surfaces or blistered areas
  • if you are allergic to any of the ingredients
  • on deep puncture wounds, animal bites, or serious burns
  • more than one week unless directed by a doctor

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean affected area
  • apply small amount 1-3 times daily
  • children under 2: consult doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packet Label Packet LabelPacket Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN4
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD4
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-5702-00First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-01First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-01First Aid Only First Aid-Burn6 in 1 CARTONCREAM64
0924-5702-02First Aid Only First Aid-Burn10 in 1 CARTONCREAM104
0924-5702-02First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-03First Aid Only First Aid-Burn12 in 1 CARTONCREAM124
0924-5702-03First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-04First Aid Only First Aid-Burn20 in 1 CARTONCREAM204
0924-5702-04First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-05First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-05First Aid Only First Aid-Burn25 in 1 CARTONCREAM254
0924-5702-06First Aid Only First Aid-Burn60 in 1 CARTONCREAM604
0924-5702-06First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-07First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-07First Aid Only First Aid-Burn144 in 1 CARTONCREAM1444

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5702FIRST AID ONLY FIRST AID-BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [ACME UNITED CORPORATION]4Current NDC, 15 package rows20241220_f31a44ff-e4ac-de1e-e053-2a95a90ab036.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-57020924-5702-00, 0924-5702-01, 0924-5702-02, 0924-5702-03, 0924-5702-04, 0924-5702-05, 0924-5702-06, 0924-5702-07
61010-5701

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
WHITE WAX7G1J5DA97FIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Only First Aid-BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEAcme United Corporationf31a44ff-e4ac-de1e-e053-2a95a90ab0362024-12-18WarningsExact identifier
ndc (package): 0924-5702-00
ndc (package): 0924-5702-02
ndc (package): 0924-5702-05
ndc (package): 0924-5702-07
ndc (package): 0924-5702-04
ndc (package): 0924-5702-03
ndc (package): 0924-5702-01
ndc (package): 0924-5702-06
ndc (product): 0924-5702
ndc11 (package): 00924570205
ndc11 (package): 00924570207
ndc11 (package): 00924570206
ndc11 (package): 00924570202
ndc11 (package): 00924570200
ndc11 (package): 00924570201
ndc11 (package): 00924570204
ndc11 (package): 00924570203
spl id: 2990220d-65fc-79b0-e063-6394a90a1736
spl set id: f31a44ff-e4ac-de1e-e053-2a95a90ab036
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESafetec of America, Inc.47cb6921-5d82-4123-a9e0-0b05d4dcb5b22024-02-07WarningsExact identifier
ndc (product): 61010-5701

Reported adverse events (FAERS/openFDA)#

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