FDA.reportPublic FDA data

Zoviro

Manufacturer
Zoviro, LLC | Jiangsu Xiaolikang Medical Technology Co., Ltd.
Effective date
2025-03-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:53

Label at a glance#

ProductZoviro
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium chloride 0.13%

OTC - PURPOSE SECTION

Purpose

Antiseptic

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if imtaton or redness develops, or if condition persists for more than 72 hours.

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.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Glycerin, Ethylhexyl- glycerin, Phenoxyethanol, Propylene Glycol, Fragrance, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil

DOSAGE & ADMINISTRATION SECTION

Directions

Rub hands thoroughly with product and allow to dry. Children under 2 years old should ask a doctor before use.

INDICATIONS & USAGE SECTION

Use

Hand sanitizing to decrease bactera on the skin.

WARNINGS SECTION

Warnings

For external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2
1038558benzalkonium chloride 0.13 % Topical ClothSY2
1038558benzalkonium chloride 0.13 % Topical SwabSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83814-001-012025-03-26C16284748780-11e7a6dab-1ef0-a2ce-e063-dadaa90aadf7Zoviro Alcohol-Free Hand Sanitizing Wipes With Tea Tree Oil
83814-001-012024-07-30C16284748780-11e7a6dab-1ef0-a2ce-e063-dadaa90aadf7Zoviro Alcohol-Free Hand Sanitizing Wipes With Tea Tree Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83814-001-01Zoviro3.136 g in 1 POUCHSWAB3.1362
83814-001-01Zoviro20 in 1 BAGSWAB202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83814-001ZOVIRO (BENZALKONIUM CHLORIDE) SWAB [ZOVIRO, LLC]2Current NDC, 2 package rows20250328_0b567ef2-a782-3daa-e063-6294a90a064e.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83814-00183814-001-01

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
PROPYLENE GLYCOL6DC9Q167V3IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT

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
ZoviroBENZALKONIUM CHLORIDEZoviro, LLC0b567ef2-a782-3daa-e063-6294a90a064e2025-03-26WarningsExact identifier
ndc (package): 83814-001-01
ndc (product): 83814-001
ndc11 (package): 83814000101
spl id: 31459c6a-45c2-bb69-e063-6294a90a58dc
spl set id: 0b567ef2-a782-3daa-e063-6294a90a064e

Reported adverse events (FAERS/openFDA)#

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