FDA.reportPublic FDA data

Antiseptic Lotion Cartridge Drug Facts

Manufacturer
Innovative BioDefense
Effective date
2021-08-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:42:08

Label at a glance#

ProductZylastXP Antiseptic
Active ingredientBENZETHONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzethonium Chloride - 0.2%

OTC - PURPOSE SECTION

Antiseptic

OTC - ASK DOCTOR SECTION

Discontinue use if irritation and redness develops. Consult a doctor if condition persists for more than 72 hours.

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping.

WARNINGS SECTION

For external use only. Avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water. Discontinue use if irritation and redness develops. Consult a doctor if condition persists for more than 72 hours. If swallowed, immediately call Poison Control Center or doctor.

INACTIVE INGREDIENT SECTION

Water, Alcohol Denat., Cetearyl Alcohol, Glycerin, Polyaminopropyl Biguanide, Dimethicone, Stearamidopropyl Dimethylamine, Benzyl Alcohol, Farnesol, Panthenol, Zinc Gluconate, Chlorhexidine Digluconate, Citric Acid, Polyquaternium-10, Tocopheryl Acetate

INDICATIONS & USAGE SECTION

Handwash to decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, immediately call Poison Control Center or doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000mL Lotion1000mL Lotion

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043325benzethonium chloride 0.2 % Topical LotionPSN3
1043325benzethonium chloride 2 MG/ML Topical LotionSCD3
1043325benzethonium chloride 0.2 % Topical LotionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57362-464-132023-01-30C16284748780-1ba0f9c33-115b-a910-e053-dadaa90a0b85Antiseptic Lotion Cartridge Drug Facts
57362-464-132021-08-26C16284748780-1ba0f9c33-115b-a910-e053-dadaa90a0b85Antiseptic Lotion Cartridge Drug Facts
57362-464-132021-01-29C16284748780-1ba0f9c33-115b-a910-e053-dadaa90a0b85Antiseptic Lotion Cartridge Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57362-464-13ZylastXP Antiseptic960 mg in 1 BOTTLE, PLASTICLOTION9603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57362-464ZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]3Legacy NDC, 1 package rows20210828_2ae1e795-11d0-2996-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57362-46457362-464-13

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
WATER059QF0KO0RIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB

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
ca7e4ef6-4799-3d54-e053-2a95a90a4e742ae1e795-11d0-2996-e054-00144ff8d46c2021-08-26WarningsExact identifier
spl id: ca7e4ef6-4799-3d54-e053-2a95a90a4e74
spl set id: 2ae1e795-11d0-2996-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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