FDA.reportPublic FDA data

Zylast Antiseptic

Manufacturer
Innovative BioDefense
Effective date
2025-10-02
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:15:33

Label at a glance#

ProductZylast Antiseptic
Active ingredientALCOHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol - 76%

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

  • To decrease bacteria on skin.
  • Recommended for repeated use.

WARNINGS SECTION

  • For external use only
  • Flammable. Keep away fro fire and flames,
  • When using this product, do not use in or near eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without wiping.
  • for children under 6, use only under adult supervision.
  • not recommended for use on infants.

INACTIVE INGREDIENT SECTION

Benzethonium Chloride, Farnesol, Hydroxypropyl Methylcellulose, Panthenol, PEG-12 Dimethicone, Polyaminopropyl Biguanide, Water

RECENT MAJOR CHANGES SECTION

  • Warnings
  • Uses
  • Stop and ask a doctor
  • Directions
  • Keep out of reach of children
  • Inactive Ingredient

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57362-465-01

Zylast Antiseptic

Antiseptic

2oz

2 oz.2 oz.

NDC 57362-465-04

Zylast Antiseptic

Antiseptic

8 oz

8ozAntiseptic8ozAntiseptic

NDC 57362-465-14

Zylast Antiseptic

Antiseptic

1000 mL

1000mL1000mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1535597ethanol 76 % Topical GelPSN7
1535597ethanol 0.76 ML/ML Topical GelSCD7
1535597ethanol 76 % Topical GelSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57362-465-012023-11-12C16284748780-1ba0f9c33-4ec8-a910-e053-dadaa90a0b85Zylast Antiseptic
57362-465-142023-11-12C16284748780-1ba0f9c33-4ec8-a910-e053-dadaa90a0b85Zylast Antiseptic
57362-465-012023-01-30C16284748780-1ba0f9c33-4ec8-a910-e053-dadaa90a0b85Zylast Antiseptic
57362-465-142023-01-30C16284748780-1ba0f9c33-4ec8-a910-e053-dadaa90a0b85Zylast Antiseptic
57362-465-012021-08-23C16284748780-1ba0f9c33-4ec8-a910-e053-dadaa90a0b85Zylast Antiseptic
57362-465-012021-01-29C16284748780-1ba0f9c33-4ec8-a910-e053-dadaa90a0b85Zylast Antiseptic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57362-465-01Zylast Antiseptic59.1 mL in 1 BOTTLE, PLASTICGEL59.17
57362-465-14Zylast Antiseptic1000 mL in 1 CARTRIDGEGEL10007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
57362-46557362-465-01, 57362-465-14

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
ALCOHOL3K9958V90MACTIB

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
Zylast AntisepticETHYL ALCOHOLInnovative BioDefense178190dc-7c68-6485-e054-00144ff8d46c2025-10-02WarningsExact identifier
ndc (package): 57362-465-14
ndc (package): 57362-465-01
ndc (product): 57362-465
ndc11 (package): 57362046514
ndc11 (package): 57362046501
spl id: 4034b4f1-0357-ad88-e063-6294a90ac287
spl set id: 178190dc-7c68-6485-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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