FDA.reportPublic FDA data

First Aid Only First Aid/Burn Cream

Manufacturer
Acme United Corporation
Effective date
2020-12-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:03

Label at a glance#

ProductFirst Aid Only First Aid/ Burn
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure9 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

Label contents#

Full prescribing information#

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites, or serious burns

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

▪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 the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, triethanolamine

Questions?

OTC - QUESTIONS SECTION

1-800-835-2263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton ImageCarton Image

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
0924-5711-012023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream
0924-5711-022023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream
0924-5711-032023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream
0924-5711-042023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream
0924-5711-052023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream
0924-5711-062023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream
0924-5711-072023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream
0924-5711-082023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream
0924-5711-092023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream
0924-5711-102023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream
0924-5711-112023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream
0924-5711-122023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream
0924-5711-132023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream
0924-5711-142023-01-30C16284748780-1f386c649-b4ff-0266-e053-dadaa90a7c1aFirst Aid Only First Aid/Burn Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-5711-01First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-02First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-02First Aid Only First Aid/ Burn6 in 1 CARTONCREAM62
0924-5711-03First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-03First Aid Only First Aid/ Burn6 in 1 BAGCREAM62
0924-5711-04First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-04First Aid Only First Aid/ Burn10 in 1 CARTONCREAM102
0924-5711-05First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-05First Aid Only First Aid/ Burn10 in 1 CARTONCREAM102
0924-5711-06First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-06First Aid Only First Aid/ Burn12 in 1 CARTONCREAM122
0924-5711-07First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-07First Aid Only First Aid/ Burn20 in 1 CARTONCREAM202
0924-5711-08First Aid Only First Aid/ Burn20 in 1 CARTONCREAM202
0924-5711-08First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-09First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-09First Aid Only First Aid/ Burn25 in 1 CARTONCREAM252
0924-5711-10First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-10First Aid Only First Aid/ Burn25 in 1 CARTONCREAM252
0924-5711-11First Aid Only First Aid/ Burn50 in 1 CARTONCREAM502
0924-5711-11First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-12First Aid Only First Aid/ Burn60 in 1 CARTONCREAM602
0924-5711-12First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-13First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-13First Aid Only First Aid/ Burn144 in 1 CARTONCREAM1442
0924-5711-14First Aid Only First Aid/ Burn0.9 g in 1 PACKETCREAM0.92
0924-5711-14First Aid Only First Aid/ Burn144 in 1 CARTONCREAM1442

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5711FIRST AID ONLY FIRST AID/ BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [ACME UNITED CORPORATION]2Legacy NDC, 27 package rows20210212_860d767d-63b9-127a-e053-2a91aa0a3f12.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-57110924-5711-04, 0924-5711-02, 0924-5711-03, 0924-5711-01, 0924-5711-05, 0924-5711-06, 0924-5711-07, 0924-5711-08, 0924-5711-09, 0924-5711-10, 0924-5711-11, 0924-5711-12, 0924-5711-13, 0924-5711-14
59898-902

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
EDETATE DISODIUM7FLD91C86KIACT
LIGHT MINERAL OILN6K5787QVPIACT
STEARIC ACID4ELV7Z65APIACT
PEG-100 STEARATEYD01N1999RIACT
CETYL ALCOHOL936JST6JCNIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT

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
b714031d-fa88-aa7e-e053-2995a90a96c4860d767d-63b9-127a-e053-2a91aa0a3f122020-12-22WarningsExact identifier
spl id: b714031d-fa88-aa7e-e053-2995a90a96c4
spl set id: 860d767d-63b9-127a-e053-2a91aa0a3f12
First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies25ebf112-8ac3-4402-9a87-00e454ab7efa2017-11-30WarningsExact identifier
ndc (product): 59898-902

Reported adverse events (FAERS/openFDA)#

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