FDA.reportPublic FDA data

81552-002 Burn Cream

Manufacturer
ROOSIN MEDICAL CO., LTD
Effective date
2021-12-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:45:40

Label at a glance#

ProductRoosin Burn
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Clean affected area Apply a small amount 1-3 times daily Children under 2: Consult doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Banzalkonium Chloride 0.13%

Lidocaine Chloride 0.5%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

External Analgesic

Antiseptic and antipyrotic

Use

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • In eyes
  • Over large areas of the body
  • For more than one week unless directed by a doctor
  • If you are allergic to any of the ingredients
  • On deep puncture wounds, animal bites, or serious burns

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

Directions

DOSAGE & ADMINISTRATION SECTION

Clean affected area

Apply a small amount 1-3 times daily

Children under 2: Consult doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water, Aloe

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81552-002-012023-01-30C16284748780-1f386c649-d3e9-0266-e053-dadaa90a7c1a81552-002 Burn Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81552-002-01Roosin Burn0.9 g in 1 TUBECREAM0.94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81552-002ROOSIN BURN (LIDOCAINE HYDROCHLORIDE) CREAM [ROOSIN MEDICAL CO., LTD]4Legacy NDC, 1 package rows20211216_29756d6f-ba17-4a72-a759-a96488d24311.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81552-00281552-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
PETROLATUM4T6H12BN9UIACT
PARAFFINI9O0E3H2ZEIACT
OCTADECANOL (MIXTURE OF ISOMERS)C6BPY2QY39IACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
GLYCEROL FORMAL3L7GR2604EIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
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
d3325ccb-0768-3f4a-e053-2a95a90aac2f29756d6f-ba17-4a72-a759-a96488d243112021-12-15WarningsExact identifier
spl id: d3325ccb-0768-3f4a-e053-2a95a90aac2f
spl set id: 29756d6f-ba17-4a72-a759-a96488d24311

Reported adverse events (FAERS/openFDA)#

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