FDA.reportPublic FDA data

OMEDI Anti-bacterial hand cream

Manufacturer
Natural Korea Co., Ltd.
Effective date
2020-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:42

Label at a glance#

ProductOMEDI Anti-bacterial hand cream
Active ingredientBENZALKONIUM CHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

No scentNo scent

OTC - ACTIVE INGREDIENT SECTION

DOSAGE & ADMINISTRATION SECTION

OTC - PURPOSE SECTION

INDICATIONS & USAGE SECTION

INACTIVE INGREDIENT SECTION

OTC - DO NOT USE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - WHEN USING SECTION

INSTRUCTIONS FOR USE SECTION

WARNINGS SECTION

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2371908benzalkonium chloride 0.05 % Topical CreamPSN1
2371908benzalkonium chloride 0.5 MG/ML Topical CreamSCD1
2371908benzalkonium chloride 0.05 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74646-3050-22023-01-30C16284748780-1f386c649-f510-0266-e053-dadaa90a7c1aOMEDI HAND CARE : OMEDI Anti-bacterial hand cream (No scent) 74646-3050-1 : TUBE 74646-3050-2 : TUBE+BOX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74646-3050-1OMEDI Anti-bacterial hand cream50 g in 1 TUBECREAM501
74646-3050-2OMEDI Anti-bacterial hand cream1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74646-3050OMEDI ANTI-BACTERIAL HAND CREAM (BENZALKONIUM CHLORIDE) CREAM [NATURAL KOREA CO., LTD.]1Legacy NDC, 2 package rows20200602_a7116cd5-3205-4bc7-e053-2995a90ac8a3.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74646-305074646-3050-1, 74646-3050-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
DIMETHICONE92RU3N3Y1OIACT
ALLANTOIN344S277G0ZIACT
ISOHEXADECANE918X1OUF1EIACT
EDETATE DISODIUM7FLD91C86KIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
WATER059QF0KO0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
GLYCERINPDC6A3C0OXIACT
UREA8W8T17847WIACT
YELLOW WAX2ZA36H0S2VIACT
MINERAL OILT5L8T28FGPIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CETYL ALCOHOL936JST6JCNIACT
POLYSORBATE 60CAL22UVI4MIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SHEA BUTTERK49155WL9YIACT
SALICYLIC ACIDO414PZ4LPZIACT
ARGININE94ZLA3W45FIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
POLYSORBATE 806OZP39ZG8HIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GRAPEFRUITO82C39RR8CIACT
ROSEMARYIJ67X351P9IACT
PEG-100 STEARATEYD01N1999RIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT

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
a7119090-af31-a6cb-e053-2a95a90ad325a7116cd5-3205-4bc7-e053-2995a90ac8a32020-06-01Exact identifier
spl id: a7119090-af31-a6cb-e053-2a95a90ad325
spl set id: a7116cd5-3205-4bc7-e053-2995a90ac8a3

Reported adverse events (FAERS/openFDA)#

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