First Aid Only Burn Spray

Manufacturer
Acme United Corporation
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:37:15

Label at a glance#

ProductLidocaine Hydrochloride
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

adults and children 2 years of age and older: spray an even layer of burn spray over affected area not more than 3-4 times daily children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 2.0%

Purpose

OTC - PURPOSE SECTION

Topical pain relief

Use

INDICATIONS & USAGE SECTION

Temporarily relieves pain associated with minor burns.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in eyes, if contact occurs rinse thoroughly with water
  • in large quantities, particularly over raw or blistered areas
OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, or persists for more than 7 days or clears up and returns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: spray an even layer of burn spray over affected area not more than 3-4 times daily
  • children under 2 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, diazolidinyl urea, propylene glycol, purified water
----------

OTC - QUESTIONS SECTION

Questions? 1.800.835.2263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle Bottle LabelBottle LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010769lidocaine HCl 2 % Topical SprayPSN3
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCD3
1010769lidocaine hydrochloride 2 % Topical SpraySY3

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
0924-0934-01Lidocaine Hydrochloride59.1 mL in 1 BOTTLE, SPRAYLIQUID59.13
0924-0934-02Lidocaine Hydrochloride118 mL in 1 BOTTLE, SPRAYLIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-0934LIDOCAINE HYDROCHLORIDE LIQUID [ACME UNITED CORPORATION]3Current NDC, 2 package rows20241115_f1f051ad-7e82-9d1a-e053-2a95a90ac7d3.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-09340924-0934-01, 0924-0934-02
61010-5100

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAcme United Corporationf1f051ad-7e82-9d1a-e053-2a95a90ac7d32024-11-12WarningsExact identifier
ndc (package): 0924-0934-02
ndc (package): 0924-0934-01
ndc (product): 0924-0934
ndc11 (package): 00924093401
ndc11 (package): 00924093402
spl id: 26bbd99c-5298-d36b-e063-6394a90aa6e6
spl set id: f1f051ad-7e82-9d1a-e053-2a95a90ac7d3
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.8eb3e7e2-26e5-430e-89aa-40a0367c637e2024-02-07WarningsExact identifier
ndc (product): 61010-5100

Reported adverse events (FAERS/openFDA)#

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