FDA.reportPublic FDA data

STERITE ELEMENT

Manufacturer
PALVI MEXICO, S.A. DE C.V.
Effective date
2021-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:08

Label at a glance#

ProductSTERITE ELEMENT
Active ingredientBENZALKONIUM CHLORIDE, DIDECYLDIMONIUM CHLORIDE
Label structure10 sections

Indications and uses

USES HAND AND SURGACE DISINFECTANT TO HELP REDUCE BACTERIA THAT POTENTIALLY CAUSE DISEASES

Dosage and administration

DIRECTIONS SPRAY STERITE NEUTRUM ON 12 TO 16 INCHES OVER HANDS, RUB AND AIR DRY, ON SURFACES APPLYING A FINE MIST, WIPE CLEAN. NO RINSING REQUIRED.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

DIDECYLDIMONIUM CHLORIDE

BENZALKONIUM CHLORIDE

PURPOSE SECTION

OTC - PURPOSE SECTION

PURPOSE

ANTIMICROBIAL

INDICATIONS AND USAGE SECTION

INDICATIONS & USAGE SECTION

USES

HAND AND SURGACE DISINFECTANT TO HELP REDUCE BACTERIA THAT POTENTIALLY CAUSE DISEASES

DOSAGE AND ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS SPRAY STERITE NEUTRUM ON 12 TO 16 INCHES OVER HANDS, RUB AND AIR DRY, ON SURFACES APPLYING A FINE MIST, WIPE CLEAN. NO RINSING REQUIRED.

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

WARNINGS AND PRECAUTIONS SECTION

DO NOT USE ON OPEN WOUNDS ON THE SKIN, EYES OR MUCOUS MEMBRANES

WARNINGS SECTION

DO NOT USE IN EYES. IF CONTACT OCCURS, FLUSH THE EYES WELL WITH PLENTY OF WATER.

STOP USE SECTION

OTC - STOP USE SECTION

STOP USE AND SEE A DOCTOR IF IRRITATION OR RASH OCCURS

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: WATER N-NONYLPHENOL, EUCALYPTOL, MANDARIN OIL, SODIUM BICARBONATE, DISODIUM EDTA.

PACKAGE LABEL PRINCIPAL DISPLAY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STERITE ELEMENTSTERITE ELEMENT

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81576-2000-22022-07-29C16284748780-1e4f33bdf-9bbe-d8a0-e053-dadaa90a6e4eSTERITE ELEMENT SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81576-2000-2STERITE ELEMENT1000 mL in 1 BOTTLE, PLASTICLIQUID10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81576-2000STERITE ELEMENT (BENZALKONIUM CHLORIDE) LIQUID [PALVI MEXICO, S.A. DE C.V.]1Legacy NDC, 1 package rows20210325_bb80ef22-bcd2-9276-e053-2995a90a6557.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81576-200081576-2000-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ACID GREEN 509B7E8Y9D0XIACT
EDETATE DISODIUM7FLD91C86KIACT
LEMON OILI9GRO824LLIACT
SODIUM BICARBONATE8MDF5V39QOIACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BACTIB
WATER059QF0KO0RIACT
N-NONYLPHENOL (MIXED ISOMERS)79F6A2ILP5IACT

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
bb80ef22-bcd3-9276-e053-2995a90a6557bb80ef22-bcd2-9276-e053-2995a90a65572021-02-16WarningsExact identifier
spl id: bb80ef22-bcd3-9276-e053-2995a90a6557
spl set id: bb80ef22-bcd2-9276-e053-2995a90a6557

Reported adverse events (FAERS/openFDA)#

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