FDA.reportPublic FDA data

72976-004 FIRST SHIELD Burn Spray

Manufacturer
Ever Ready First Aid
Effective date
2024-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:16

Label at a glance#

ProductFIRST SHIELD
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Lidocaine HCI 2.0%

OTC - PURPOSE SECTION

Purpose

Topical pain relief

INDICATIONS & USAGE SECTION

Uses

Temporary pain relief associated with minor burns

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • 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 a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • spray an over layer of burn spray over cleaned affected area not more than 3-4 times daily
  • not to be used on children under 12 years of age

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydroxypropyl methylcllulose, melaleuce alterniflia (tea tree) leaf oil, octoxynol 9,PEEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

OTC - QUESTIONS SECTION

Questions or comments？ 800-325-4655

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010769lidocaine HCl 2 % Topical SprayPSN2
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCD2
1010769lidocaine hydrochloride 2 % Topical SpraySY2

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
72976-004-01FIRST SHIELD60 mL in 1 BOTTLE, SPRAYSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72976-004FIRST SHIELD (LIDOCAINE HCI) SPRAY [EVER READY FIRST AID]2Current NDC, Legacy NDC, 1 package rows20240116_e022bf8f-3dd8-de22-e053-2995a90a219b.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
72976-00472976-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
GLYCERINPDC6A3C0OXIACT
TEA TREE OILVIF565UC2GIACT
HYPROMELLOSES3NXW29V3WOIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
OCTOXYNOL 97JPC6Y25QSIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT

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 SHIELDLIDOCAINE HCIEver Ready First Aide022bf8f-3dd8-de22-e053-2995a90a219b2024-01-15WarningsExact identifier
ndc (package): 72976-004-01
ndc (product): 72976-004
ndc11 (package): 72976000401
spl id: 0f0050be-f3b2-c555-e063-6394a90a2ea9
spl set id: e022bf8f-3dd8-de22-e053-2995a90a219b

Reported adverse events (FAERS/openFDA)#

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