FDA.reportPublic FDA data

First Aid Burn

Manufacturer
Unishield
Effective date
2019-10-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:44

Label at a glance#

ProductFirst Aid Burn
Active ingredientLidocaine Hydrochloride
Label structure9 sections

Indications and uses

Temporary pain relief for minor burns

Dosage and administration

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

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

Uses

INDICATIONS & USAGE SECTION

Temporary pain relief for minor burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water

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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, germaben II, propylene glycol, purified water

Questions?

OTC - QUESTIONS SECTION

call 1-800-480-5855

Principal Display Panel - 59.1 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UniShield

FIRST AID
BURN
SPRAY

For Temporary
Pain Relief of
Minor Burns

NET CONTENTS 2 FL.OZ. (59.1 ML)

Distributed by: UniShield, San Fernando, CA 91340
Made in USA

Principal Display Panel - 59.1 mL Bottle Label
Principal Display Panel - 59.1 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010769lidocaine HCl 2 % Topical SprayPSN1
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCD1
1010769lidocaine hydrochloride 2 % Topical SpraySY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49314-5100-42021-01-29C16284748780-1ba0f9c33-5147-a910-e053-dadaa90a0b85aebcfa2a-fdd8-4118-abe3-c8579a614cc7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49314-5100-4First Aid Burn59.1 mL in 1 BOTTLE, SPRAYSPRAY59.11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49314-5100FIRST AID BURN (LIDOCAINE HYDROCHLORIDE) SPRAY [UNISHIELD ]1Legacy NDC, 1 package rows20191007_aebcfa2a-fdd8-4118-abe3-c8579a614cc7.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49314-510049314-5100-4

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
Lidocaine HydrochlorideV13007Z41AACTIR
aloe vera leafZY81Z83H0XIACT
propylene glycol6DC9Q167V3IACT
diazolidinyl ureaH5RIZ3MPW4IACT
water059QF0KO0RIACT

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
06a2ae14-a264-4da5-97cf-d061a0257c46aebcfa2a-fdd8-4118-abe3-c8579a614cc72019-10-07WarningsExact identifier
spl id: 06a2ae14-a264-4da5-97cf-d061a0257c46
spl set id: aebcfa2a-fdd8-4118-abe3-c8579a614cc7

Reported adverse events (FAERS/openFDA)#

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