FDA.reportPublic FDA data

COVIXYL-G

Manufacturer
Salvacion USA, Inc. | Salvacion USA Inc.
Effective date
2022-02-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:07:17

Label at a glance#

ProductCOVIXYL-G
Active ingredientBENZALKONIUM CHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

Package display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Purpose - Antiseptic

OTC - PURPOSE SECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Directions

INDICATIONS & USAGE SECTION

Do not use

OTC - STOP USE SECTION

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

Nasal Antiseptic soution, Benzalkonium Chloride 0.13%

DOSAGE & ADMINISTRATION SECTION

Solution / drops and Benzalkonium Chloride 0.13%

DOSAGE FORMS & STRENGTHS SECTION

Inactive ingredients

INACTIVE INGREDIENT SECTION

Questions ? Call

OTC - QUESTIONS SECTION

Warngins For extenal use only

SAFE HANDLING WARNING SECTION

Warning for external use only

WARNINGS SECTION

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80857-100-012022-03-01C16284748780-1d6a99b39-98ee-a426-e053-dadaa90af4c2b3d70f48-ee6a-c9c0-e053-2995a90a7b60
80857-100-012022-01-28C16284748780-1d6a99b39-98ee-a426-e053-dadaa90af4c2b3d70f48-ee6a-c9c0-e053-2995a90a7b60

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80857-10080857-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERINPDC6A3C0OXIACT

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
f7ebe681-0976-ede6-e053-6294a90ac04bb3d70f48-ee6a-c9c0-e053-2995a90a7b602023-03-27WarningsExact identifier
spl set id: b3d70f48-ee6a-c9c0-e053-2995a90a7b60

Reported adverse events (FAERS/openFDA)#

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