FDA.reportPublic FDA data

Zylast Antiseptic

Manufacturer
Innovative BioDefense
Effective date
2020-08-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:25:50

Label at a glance#

ProductZylast Antiseptic
Active ingredientALCOHOL
Label structure12 sections

Storage and handling

Store at 20-25 degrees Celsius (68-77 degrees Farenheit)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol - 76%

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

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

OTC - ASK DOCTOR SECTION

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

WARNINGS SECTION

  • For external use only.
  • Flammable. Keep away from fire or flames

OTC - WHEN USING SECTION

  • 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 - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact 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 with adult supervision.
  • Not recommended for use on infants.

STORAGE AND HANDLING SECTION

  • Store at 20-25 degrees Celsius (68-77 degrees Farenheit)

INACTIVE INGREDIENT SECTION

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

RECENT MAJOR CHANGES SECTION

  1. Indications and Usage
  2. Warnings and Precaution
  3. Dosage and Administration
  4. When Using This Product
  5. Order of Sections

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57362-465-04

Zylast Antiseptic 8oz

Broad Spectrum

Antimicrobial

Non-Irritating

Zylast 8 ozZylast 8 oz

NDC: 57362-465-48

CB Antiseptic labelCB Antiseptic label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1535597ethanol 76 % Topical GelPSN3
1535597ethanol 0.76 ML/ML Topical GelSCD3
1535597ethanol 76 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57362-465-042021-07-23C16284748780-1c7ccaba7-1512-fd44-e053-dadaa90aa01bAntiseptic 8oz Drug Facts
57362-465-482021-07-23C16284748780-1c7ccaba7-1512-fd44-e053-dadaa90aa01bAntiseptic 8oz Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57362-465-04Zylast Antiseptic236.6 mL in 1 BOTTLE, PLASTICGEL236.63
57362-465-48Zylast Antiseptic250 mL in 1 BOTTLE, PLASTICGEL2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57362-465ZYLAST ANTISEPTIC (ETHYL ALCOHOL) GEL [INNOVATIVE BIODEFENSE]3Current NDC, Legacy NDC, 2 package rows20200827_17a70b04-3e61-27ae-e054-00144ff8d46c.zip

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
57362-46557362-465-04, 57362-465-48

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
ALCOHOL3K9958V90MACTIB
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zylast AntisepticETHYL ALCOHOLInnovative BioDefense178190dc-7c68-6485-e054-00144ff8d46c2025-10-02WarningsExact identifier
ndc (product): 57362-465
adcfc558-2230-e6e7-e053-2995a90a597517a70b04-3e61-27ae-e054-00144ff8d46c2020-08-26WarningsExact identifier
spl id: adcfc558-2230-e6e7-e053-2995a90a5975
spl set id: 17a70b04-3e61-27ae-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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