FDA.reportPublic FDA data

ZylastXP Antiseptic Foaming

Manufacturer
Innovative Biodefense
Effective date
2023-01-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:46

Label at a glance#

ProductZylastXP Antiseptic Foaming
Active ingredientBENZETHONIUM CHLORIDE
Label structure12 sections

Indications and uses

Handwash to decrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

Wet hands and forearms. Apply one pump to hands and forearms thoroughly for 15 seconds or more. Rinse and repeat. For children under 6, use only with adult supervision.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzethonium Chloride - 0.20%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Handwash to decrease bacteria on the skin.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

  • For external use only.
  • When using this product, do not use in or near eyes. In case of contact, rinse eyes throroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Irritation or redness develops.

Condition persists for more than 72 hours.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands and forearms. Apply one pump to hands and forearms thoroughly for 15 seconds or more. Rinse and repeat. For children under 6, use only with adult supervision.

Other Inforamtion

SPL UNCLASSIFIED SECTION

  • Store at 20-25°C (68-77°F) 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denatured, Aloe Barbadenis Lead Extract, Butylene Glycol, Cetrimonium Chloride, Citric Acid, Cocamidopropyl Betaiine, Farnesol, Fragrance, Glycerin, Lauramine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, Polyaminopropyl Biguanide, Polyquaternium-10, PPG-12 Hydroxyethyl Cocamide, Water, Zinc Gluconate

RECENT MAJOR CHANGES SECTION

  • Uses section
  • Warnings section
  • Inactive Ingredients section
  • Directions section

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57362-467-01
Zylast
Extended Protection
Broad Spectrum
Antimicrobial
Antiseptic

Foaming Soap
8.25 oz

8.25 oz8.25 oz

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57362-467-02
Zylast
Extended Protection
Broad Spectrum
Antimicrobial
Antiseptic

Foaming Soap
1000mL (33.8oz)

1000mL1000mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1243889benzethonium chloride 0.2 % Medicated Liquid SoapPSN4
1243889benzethonium chloride 2 MG/ML Medicated Liquid SoapSCD4
1243889benzethonium chloride 0.2 % Medicated Liquid SoapSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57362-467-012023-12-17C16284748780-1c7ccaba7-114c-fd44-e053-dadaa90aa01bZylast Foaming Soap
57362-467-022023-12-17C16284748780-1c7ccaba7-114c-fd44-e053-dadaa90aa01bZylast Foaming Soap
57362-467-482023-12-17C16284748780-1c7ccaba7-114c-fd44-e053-dadaa90aa01bZylast Foaming Soap
57362-467-012023-01-30C16284748780-1c7ccaba7-114c-fd44-e053-dadaa90aa01bZylast Foaming Soap
57362-467-022023-01-30C16284748780-1c7ccaba7-114c-fd44-e053-dadaa90aa01bZylast Foaming Soap
57362-467-482023-01-30C16284748780-1c7ccaba7-114c-fd44-e053-dadaa90aa01bZylast Foaming Soap
57362-467-012021-08-23C16284748780-1c7ccaba7-114c-fd44-e053-dadaa90aa01bZylast Foaming Soap
57362-467-022021-08-23C16284748780-1c7ccaba7-114c-fd44-e053-dadaa90aa01bZylast Foaming Soap
57362-467-482021-08-23C16284748780-1c7ccaba7-114c-fd44-e053-dadaa90aa01bZylast Foaming Soap
57362-467-012021-07-23C16284748780-1c7ccaba7-114c-fd44-e053-dadaa90aa01bZylast Foaming Soap
57362-467-022021-07-23C16284748780-1c7ccaba7-114c-fd44-e053-dadaa90aa01bZylast Foaming Soap
57362-467-482021-07-23C16284748780-1c7ccaba7-114c-fd44-e053-dadaa90aa01bZylast Foaming Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57362-467-01ZylastXP Antiseptic Foaming244 mL in 1 BOTTLESOAP2444
57362-467-02ZylastXP Antiseptic Foaming1000 mL in 1 BOTTLESOAP10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57362-467ZYLASTXP ANTISEPTIC FOAMING (BENZETHONIUM CHLORIDE) SOAP [INNOVATIVE BIODEFENSE]4Current NDC, Legacy NDC, 2 package rows20231218_86857d95-56ce-2eb4-e053-2a91aa0ad557.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57362-46757362-467-01, 57362-467-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
FARNESOLEB41QIU6JLIACT
GLYCERINPDC6A3C0OXIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
POLIHEXANIDE322U039GMFIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB
WATER059QF0KO0RIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
PPG-2 HYDROXYETHYL COCAMIDE34N07GUJ3XIACT

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
ZylastXP Antiseptic FoamingBENZETHONIUM CHLORIDEInnovative Biodefense86857d95-56ce-2eb4-e053-2a91aa0ad5572023-01-01WarningsExact identifier
ndc (package): 57362-467-02
ndc (package): 57362-467-01
ndc (product): 57362-467
ndc11 (package): 57362046702
ndc11 (package): 57362046701
spl id: 050d7188-449a-68e3-e063-6394a90af600
spl set id: 86857d95-56ce-2eb4-e053-2a91aa0ad557

Reported adverse events (FAERS/openFDA)#

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