FDA.reportPublic FDA data

FIRST SHIELD Burn Cream

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 00:07:19

Label at a glance#

ProductFIRST SHIELD
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

OTC - PURPOSE SECTION

Purpose

First Aid Antiseptic

Topical Analgesic

INDICATIONS & USAGE SECTION

Uses

  • Temporary relief of pain associated with minor cuts, scrapes, and burns.
  • Helps protect against harmful bacteria.

WARNINGS SECTION

Warnings

For external use only.

If swallowed, get medical help or contact a Poison Control Center directly.

OTC - DO NOT USE SECTION

Do not use

  • in eyes
  • in large quantities
  • over raw or blisteres areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage

OTHER SAFETY INFORMATION

Other Information

  • store in a cool dry area 15° to 25C° (59° to 79°F)
  • tampler evident sealed packets
  • do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate, Mineral oil, Maltodextrin, Propylene glycol, Purified water, PEG-100 Stearate, Phenoxyethanol, Stearic acid, Triethanolamine

OTC - QUESTIONS SECTION

Questions?

Call: 800-325-4655

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of pouch labelimage of pouch label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN2
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD2
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY2

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
72976-008-01FIRST SHIELD0.9 g in 1 POUCHCREAM0.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72976-008FIRST SHIELD (BENZALKONIUM CHLORIDE, LIDOCAINE HCI) CREAM [EVER READY FIRST AID]2Current NDC, Legacy NDC, 1 package rows20240116_ee198aa1-ad0d-9185-e053-2a95a90a6595.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72976-00872976-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MINERAL OILT5L8T28FGPIACT
MALTODEXTRIN7CVR7L4A2DIACT
PEG-100 STEARATEYD01N1999RIACT
STEARIC ACID4ELV7Z65APIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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 SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aidee198aa1-ad0d-9185-e053-2a95a90a65952024-01-15WarningsExact identifier
ndc (package): 72976-008-01
ndc (product): 72976-008
ndc11 (package): 72976000801
spl id: 0eff7672-ef8d-8a09-e063-6394a90a62e9
spl set id: ee198aa1-ad0d-9185-e053-2a95a90a6595

Reported adverse events (FAERS/openFDA)#

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