FDA.reportPublic FDA data

Zylast Antiseptic S

Manufacturer
Innovative BioDefense
Effective date
2023-01-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:00:16

Label at a glance#

ProductZylast Antiseptic S
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

To decrease bacteria on skin. Recommended for repeated use.

Dosage and administration

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.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol - 76%

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warning Section

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 - ASK DOCTOR SECTION

Discontinue use if irritation and redness develops. Consult a doctor if 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.

Directions

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.

INACTIVE INGREDIENT SECTION

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

RECENT MAJOR CHANGES SECTION

  • Inidication of Use
  • Warrnings
  • When using this product
  • Stop use and ask a doctor
  • Keep out of reach of children
  • Directions
  • Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57702-466-16

Zylast Antiseptic S

1000mL

Broad Spectrum

Antimicrobial

1000mL1000mL

NDC 57362-466-10

Zylast Antiseptic S 10mL vial

10mL10mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1491797ethanol 76 % Topical SolutionPSN5
1491797ethanol 0.76 ML/ML Topical SolutionSCD5
1491797ethanol 76 % Topical SolutionSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57362-466-162022-04-16C16284748780-1c7ccaba7-114f-fd44-e053-dadaa90aa01bZylast Antiseptic S
57362-466-172022-04-16C16284748780-1c7ccaba7-114f-fd44-e053-dadaa90aa01bZylast Antiseptic S
57362-466-412022-04-16C16284748780-1c7ccaba7-114f-fd44-e053-dadaa90aa01bZylast Antiseptic S
57362-466-162021-07-23C16284748780-1c7ccaba7-114f-fd44-e053-dadaa90aa01bZylast Antiseptic S
57362-466-172021-07-23C16284748780-1c7ccaba7-114f-fd44-e053-dadaa90aa01bZylast Antiseptic S
57362-466-412021-07-23C16284748780-1c7ccaba7-114f-fd44-e053-dadaa90aa01bZylast Antiseptic S

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57362-466-16Zylast Antiseptic S1000 mL in 1 CARTRIDGELIQUID10005
57362-466-17Zylast Antiseptic S10 mL in 1 VIAL, GLASSLIQUID105
57362-466-41Zylast Antiseptic S10 mL in 1 VIAL, GLASSLIQUID105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57362-466ZYLAST ANTISEPTIC S (ETHYL ALCOHOL) LIQUID [INNOVATIVE BIODEFENSE]5Current NDC, Legacy NDC, 3 package rows20231113_86857d95-56b4-2eb4-e053-2a91aa0ad557.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
57362-46657362-466-16, 57362-466-17, 57362-466-41

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 Antiseptic SETHYL ALCOHOLInnovative BioDefense86857d95-56b4-2eb4-e053-2a91aa0ad5572023-01-01WarningsExact identifier
ndc (package): 57362-466-16
ndc (package): 57362-466-41
ndc (package): 57362-466-17
ndc (product): 57362-466
ndc11 (package): 57362046616
ndc11 (package): 57362046641
ndc11 (package): 57362046617
spl id: 050d4721-0bd7-0fdc-e063-6394a90aa7ff
spl set id: 86857d95-56b4-2eb4-e053-2a91aa0ad557

Reported adverse events (FAERS/openFDA)#

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