FDA.reportPublic FDA data

Zylast Antiseptic

Manufacturer
Bocchi Laboratories Inc.
Effective date
2014-03-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:38:42

Label at a glance#

ProductZylast Antiseptic
Active ingredientALCOHOL
Label structure18 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 76%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • For external use only.
  • Flammable. Keep away from flame.
  • Discontinue use if irritation and redness develops. Consult a doctor if condition persists for more than 72 hours.  

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, immediately call Poison Control Center or doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

  • Store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 76%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • For external use only.
  • Flammable, keepaway from flame.
  • 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.

Directions

INDICATIONS & USAGE SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

  •  Store at 20-25°C (68-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57702-464-00
Zylast
Broad Spectrum
Antimicrobial
Antiseptic
2 fl oz/ 59.1 mL

NDC 57702-464-00 Zylast Broad Spectrum Antimicrobial Antiseptic 2 fl oz/ 59.1 mL
NDC 57702-464-00 Zylast Broad Spectrum Antimicrobial Antiseptic 2 fl oz/ 59.1 mL

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57702-464-03
Zylast
Broad Spectrum
Antimicrobial
Antiseptic
8 fl oz 236.6 mL

Zylast Broad Spectrum Antimicrobial Antiseptic 8 fl oz 236.6 mL
Zylast Broad Spectrum Antimicrobial Antiseptic 8 fl oz 236.6 mL

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57702-464-13
Zylast
Broad Spectrum
Antimicrobial
Antiseptic
1000mL (33.8oz)

NDC 57702-464-13 Zylast Broad Spectrum Antimicrobial Antiseptic 1000mL (33.8oz)
NDC 57702-464-13 Zylast Broad Spectrum Antimicrobial Antiseptic 1000mL (33.8oz)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1491797ethanol 76 % Topical SolutionPSN3
1491797ethanol 0.76 ML/ML Topical SolutionSCD3
1491797ethanol 76 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57702-464-002019-11-27C16284748780-19855e2a2-3591-60a7-e053-dbdaa90a05bdZylast Antiseptic Drug Facts
57702-464-032019-11-27C16284748780-19855e2a2-3591-60a7-e053-dbdaa90a05bdZylast Antiseptic Drug Facts
57702-464-132019-11-27C16284748780-19855e2a2-3591-60a7-e053-dbdaa90a05bdZylast Antiseptic Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57702-464-00Zylast Antiseptic59.1 mL in 1 BOTTLELIQUID59.13
57702-464-03Zylast Antiseptic236.6 mL in 1 BOTTLELIQUID236.63
57702-464-13Zylast Antiseptic1000 mL in 1 BOTTLELIQUID10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57702-464ZYLAST ANTISEPTIC (ETHYL ALCOHOL) LIQUID [BOCCHI LABORATORIES INC.]3Legacy NDC, 3 package rows20140314_dbaf3296-49d4-472a-909b-df46556095af.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M3
ALCOHOLACTIVE MOIETY3K9958V90M3
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D057443
FARNESOLINACTIVE INGREDIENTEB41QIU6JL3
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z3
POLIHEXANIDEINACTIVE INGREDIENT322U039GMF3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57702-46457702-464-00, 57702-464-03, 57702-464-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
FARNESOLEB41QIU6JLIACT
WATER059QF0KO0RIACT
POLIHEXANIDE322U039GMFIACT
PANTHENOLWV9CM0O67ZIACT
BENZETHONIUM CHLORIDEPH41D05744IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION / INTRAVENOUS1 mgExact identifier — unii candidate
6 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744SOLUTION / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744CREAM / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744SOLUTION/ DROPS / AURICULAR (OTIC)0.02 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
6 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates

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
14f30d68-789e-40d2-aacd-cb9f8556cc2ddbaf3296-49d4-472a-909b-df46556095af2014-03-13WarningsExact identifier
spl id: 14f30d68-789e-40d2-aacd-cb9f8556cc2d
spl set id: dbaf3296-49d4-472a-909b-df46556095af

Reported adverse events (FAERS/openFDA)#

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