FDA.reportPublic FDA data

First Aid Burn Cream

Manufacturer
Davemed Healthcare Co., Ltd
Effective date
2020-02-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:03:35

Label at a glance#

ProductFirst Aid Burn Cream
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns.

Dosage and administration

Clean affected area apply small amount not more than 3 times daily maybe covered with a sterile bondage

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine HCL 0.5%

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic, external analgesic

Temporary relief of pain associated with minor burns

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns.

WARNINGS SECTION

EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, get medical help or contact a Poison Control Center right away.

DO NOT USE

OTC - DO NOT USE SECTION

DO NOT USE:

  • in eyes
  • in large quantities
  • over raw blistered areas or on deep punctured wounds, animal bites or serious burns
  • for more than one week

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean affected area
  • apply small amount not more than 3 times daily
  • maybe covered with a sterile bondage

Inactive ingredients

INACTIVE INGREDIENT SECTION

inactive ingredient

Other Information

OTHER SAFETY INFORMATION

Other Information

Store at room temperature

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN4
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD4
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY4

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70897-001-012024-01-30C16284748780-19d75b9d0-3cdc-f424-e053-dadaa90a57ceFirst Aid Burn Cream
70897-001-022024-01-30C16284748780-19d75b9d0-3cdc-f424-e053-dadaa90a57ceFirst Aid Burn Cream
70897-001-012020-02-03C16284748780-19d75b9d0-3cdc-f424-e053-dadaa90a57ceFirst Aid Burn Cream
70897-001-022020-02-03C16284748780-19d75b9d0-3cdc-f424-e053-dadaa90a57ceFirst Aid Burn Cream
70897-001-012020-01-31C16284748780-19d75b9d0-3cdc-f424-e053-dadaa90a57ceFirst Aid Burn Cream
70897-001-022020-01-31C16284748780-19d75b9d0-3cdc-f424-e053-dadaa90a57ceFirst Aid Burn Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70897-001-01First Aid Burn Cream0.9 g in 1 BAGCREAM0.94
70897-001-02First Aid Burn Cream42.5 g in 1 BAGCREAM42.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70897-001FIRST AID BURN CREAM (LIDOCAINE) CREAM [DAVEMED HEALTHCARE CO., LTD]4Legacy NDC, 2 package rows20200204_39a4f401-9fae-2e1a-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70897-00170897-001-01, 70897-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
MINERAL OILT5L8T28FGPIACT
METHYL PARAOXONUE1A2XL95HIACT
PETROLATUM4T6H12BN9UIACT
DIISOPROPYL PARAOXONR90A2849YVIACT
ALLANTOIN344S277G0ZIACT
TRIETHANOLAMINE SULFATEMV1V89M17OIACT
STEARIC ACID D7T3B081197XIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARYL ALCOHOL2KR89I4H1YIACT

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
9db29e83-9948-14af-e053-2995a90ac69839a4f401-9fae-2e1a-e054-00144ff88e882020-02-03WarningsExact identifier
spl id: 9db29e83-9948-14af-e053-2995a90ac698
spl set id: 39a4f401-9fae-2e1a-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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