FDA.reportPublic FDA data

First Aid Only First Aid/Burn Cream

Manufacturer
Acme United Corporation
Effective date
2024-11-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:37:42

Label at a glance#

ProductFirst Aid Only First Aid/Burn
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure10 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

Adults - Clean the affected area, apply a small amount of product (equal to the surface area of a fingertip) 1 to 3 times daily. Children under 2- Consult a doctor

Storage and handling

Store in a cool dry area 150 – 250C (590 – 770F)

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.

OTC - DO NOT USE SECTION

Do not use ▪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

OTC - STOP USE SECTION

  • Stop use and ask a doctor if ▪condition worsens or clears up and occurs again within a few days ▪symptoms persist for more than 7 days ▪a rash or allergic reaction occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults - Clean the affected area, apply a small amount of product (equal to the surface area of a fingertip) 1 to 3 times daily.

Children under 2- Consult a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store in a cool dry area 150 – 250C (590 – 770F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, ceteth-20, cetostearyl alcohol, dimethicone, glycerin, glyceryl monostearate, isopropyl myristate, methylcellulose, purified water, sodium EDTA, methyl paraben sodium, propylparaben sodium

OTC - QUESTIONS SECTION

Questions 1.800.835.2263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton label Carton LabelCarton Label

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
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
0924-5011-00First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-01First Aid Only First Aid/Burn10 in 1 CARTONCREAM102
0924-5011-01First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-02First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-02First Aid Only First Aid/Burn12 in 1 CARTONCREAM122
0924-5011-03First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-03First Aid Only First Aid/Burn25 in 1 CARTONCREAM252
0924-5011-04First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-04First Aid Only First Aid/Burn144 in 1 CARTONCREAM1442

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5011FIRST AID ONLY FIRST AID/BURN (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) CREAM [ACME UNITED CORPORATION]2Current NDC, Legacy NDC, 9 package rows20241119_caa67a05-bdbd-c380-e053-2995a90a0bf1.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-50110924-5011-00, 0924-5011-02, 0924-5011-03, 0924-5011-01, 0924-5011-04
50382-022

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETETH-20I835H2IHHXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
METHYLCELLULOSE (25 MPA.S)BI55GG2WLIIACT
WATER059QF0KO0RIACT
EDETATE SODIUMMP1J8420LUIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEAcme United Corporationcaa67a05-bdbd-c380-e053-2995a90a0bf12024-11-17WarningsExact identifier
ndc (package): 0924-5011-00
ndc (package): 0924-5011-02
ndc (package): 0924-5011-04
ndc (package): 0924-5011-01
ndc (package): 0924-5011-03
ndc (product): 0924-5011
ndc11 (package): 00924501104
ndc11 (package): 00924501103
ndc11 (package): 00924501101
ndc11 (package): 00924501100
ndc11 (package): 00924501102
spl id: 27225914-f582-736b-e063-6394a90ad1c5
spl set id: caa67a05-bdbd-c380-e053-2995a90a0bf1

Reported adverse events (FAERS/openFDA)#

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