FDA.reportPublic FDA data

82416-0050-02 ENVISIONARY LIFE HEALTH SCIENCE LLC HAND CREAM ANTI-BACTERIAL

Manufacturer
Envisionary Life Health Science LLC | Natural Korea Co., Ltd.
Effective date
2021-11-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:45:06

Label at a glance#

ProductHANDCREAM ANTI-BACTERIAL
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Indications and uses

to decrease bacteria on the skin.

Dosage and administration

Apply on hands and rub in until fully absorbed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.05%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Warnings

WARNINGS SECTION

For external use only.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Poison Control Center right away.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes.
  • If contact occurs, rinse eyes throughly with water.

Uses

INDICATIONS & USAGE SECTION

to decrease bacteria on the skin.

Stop use and ask a doctor if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • irritation and redness develop.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply on hands and rub in until fully absorbed.

OTHER SAFETY INFORMATION

  • Store below 110 F (43 C)
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82416-0050-282416-0050-2

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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
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
82416-0050-22023-01-30C16284748780-1f386c64a-00d8-0266-e053-dadaa90a7c1a82416-0050-02 ENVISIONARY LIFE HEALTH SCIENCE LLC HAND CREAM ANTI-BACTERIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82416-0050-2HANDCREAM ANTI-BACTERIAL1 in 1 BOXCREAM11
82416-0050-2HANDCREAM ANTI-BACTERIAL50 mL in 1 TUBECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82416-0050HANDCREAM ANTI-BACTERIAL (BENZALKONIUM CHLORIDE) CREAM [ENVISIONARY LIFE HEALTH SCIENCE LLC]1Legacy NDC, 2 package rows20211125_d18546e0-1592-2c17-e053-2995a90a1c3a.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82416-005082416-0050-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
ROSEMARYIJ67X351P9IACT
DIMETHICONE92RU3N3Y1OIACT
STEARIC ACID4ELV7Z65APIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PANTHENOLWV9CM0O67ZIACT
GRAPEFRUITO82C39RR8CIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
UREA8W8T17847WIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 60CAL22UVI4MIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAMELLIA JAPONICA SEED OILU37N0S910TIACT
PEG-100 STEARATEYD01N1999RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SALICYLIC ACIDO414PZ4LPZIACT
ARGININE94ZLA3W45FIACT
EDETATE DISODIUM7FLD91C86KIACT
OLIVE OIL6UYK2W1W1EIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
DIPROPYLENE GLYCOLE107L85C40IACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
ROSMARINUS OFFICINALIS FLOWERNR1A27F29OIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
ALLANTOIN344S277G0ZIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
CETYL ALCOHOL936JST6JCNIACT
MYRRH OILH74221J5J4IACT
LEMON OILI9GRO824LLIACT
MINERAL OILT5L8T28FGPIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ISOHEXADECANE918X1OUF1EIACT

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
d18546e0-1593-2c17-e053-2995a90a1c3ad18546e0-1592-2c17-e053-2995a90a1c3a2021-11-24WarningsExact identifier
spl id: d18546e0-1593-2c17-e053-2995a90a1c3a
spl set id: d18546e0-1592-2c17-e053-2995a90a1c3a

Reported adverse events (FAERS/openFDA)#

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