FDA.reportPublic FDA data

First Aid Only Burn Gel

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 Burn
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Temporarily relieves pain associated with minor burns

Dosage and administration

Adults and children 2 years and over: 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: consult a doctor

Label contents#

Full prescribing information#

• ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 2%

• PURPOSE

OTC - PURPOSE SECTION

External Analgesic

USES

INDICATIONS & USAGE SECTION

Temporarily relieves pain associated with minor burns

WARNINGS

WARNINGS SECTION

For external use only.

Avoid contact with eyes

Do not use

OTC - DO NOT USE SECTION

▪ in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

OTC - STOP USE SECTION

▪condition worsens

▪symptoms persist for more than 7 days

▪symptoms clear up and occur again in a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

. If swallowed get medical help or contact Poison Control immediately

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and over:

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: consult a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylparaben, Propylene Glycol, Purified water, Tea Tree Leaf Oil, Triethanolamine.

SPL UNCLASSIFIED SECTION


QUESTIONS 800-835-2263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011852lidocaine HCl 2 % Topical GelPSN2
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD2
1011852lidocaine hydrochloride 2 % Topical JellySY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-5010-00First Aid Only Burn3.5 g in 1 PACKETGEL3.52
0924-5010-01First Aid Only Burn3.5 g in 1 PACKETGEL3.52
0924-5010-01First Aid Only Burn6 in 1 CARTONGEL62
0924-5010-02First Aid Only Burn3.5 g in 1 PACKETGEL3.52
0924-5010-02First Aid Only Burn25 in 1 CARTONGEL252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5010FIRST AID ONLY BURN (LIDOCAINE HYDROCHLORIDE) GEL [ACME UNITED CORPORATION]2Current NDC, Legacy NDC, 5 package rows20241119_9af39fcd-0a57-26d0-e053-2a95a90a99a0.zip

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
0924-50100924-5010-01, 0924-5010-02, 0924-5010-00
50382-020

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
TEA TREE OILVIF565UC2GIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
IMIDUREAM629807ATLIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML · Source PDF

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 BurnLIDOCAINE HYDROCHLORIDEAcme United Corporation9af39fcd-0a57-26d0-e053-2a95a90a99a02024-11-17WarningsExact identifier
ndc (package): 0924-5010-00
ndc (package): 0924-5010-02
ndc (package): 0924-5010-01
ndc (product): 0924-5010
ndc11 (package): 00924501002
ndc11 (package): 00924501001
ndc11 (package): 00924501000
spl id: 27223959-ea8a-210b-e063-6294a90a4bc6
spl set id: 9af39fcd-0a57-26d0-e053-2a95a90a99a0

Reported adverse events (FAERS/openFDA)#

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