FDA.reportPublic FDA data

LIDOCAINE HYDROCHLORIDE - Acme United Corporation

Manufacturer
Acme United Corporation
Effective date
2026-05-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-03 18:04:06

Label at a glance#

ProductFirst Aid Only Lidocaine Hydrochloride Analgesic Burn Gel
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

• adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily • children under 2 years of age: do not use consult a doctor

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 2%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain associated with • minor burns

Warnings

WARNINGS SECTION

For external use only

Avoid Contact with eyes

Do not use

OTC - DO NOT USE SECTION

• on wounds or damaged skin • in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily • children under 2 years of age: do not use consult a doctor

Other information

SPL UNCLASSIFIED SECTION

•store at room temperature 15-30°C (59-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosscopolymer, carbomer, glycerin, imidurea, methylparaben, propylene glycol, propylparaben, purified water, tea tree oil, trolamine

Questions?

OTC - QUESTIONS SECTION

800-835-2263

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton LabelCarton Label

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130738743130103GTIN-13: 0738743130103
EAN-13: 0738743130103
GTIN-12: 738743130103
UPC-A: 738743130103
GTIN storage (14 digits): 00738743130103		807113-001-revA_FDA.jpg

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

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-50040924-5004-00, 0924-5004-01, 0924-5004-03, 0924-5004-17
61040-230

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
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
GLYCERINPDC6A3C0OXIACT
IMIDUREAM629807ATLIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
TEA TREE OILVIF565UC2GIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER0A5MM307FCIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Only Lidocaine Hydrochloride Analgesic Burn GelLIDOCAINE HYDROCHLORIDEAcme United Corporation5258cef2-0e5c-4ccd-e063-6394a90a9e5c2026-05-21WarningsExact identifier
ndc (package): 0924-5004-03
ndc (package): 0924-5004-00
ndc (package): 0924-5004-01
ndc (package): 0924-5004-17
ndc (product): 0924-5004
ndc11 (package): 00924500400
ndc11 (package): 00924500417
ndc11 (package): 00924500401
ndc11 (package): 00924500403
spl id: 5258cc02-81e4-3363-e063-6294a90a82e5
spl set id: 5258cef2-0e5c-4ccd-e063-6394a90a9e5c

Reported adverse events (FAERS/openFDA)#

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