FDA.reportPublic FDA data

Zylast Antiseptic Lotion K

Manufacturer
Innovative Biodefense
Effective date
2023-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:00:16

Label at a glance#

ProductZylast Antiseptic K
Active ingredientBENZALKONIUM CHLORIDE
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.

Storage and handling

Store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride- 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on 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 thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Irritation or redness develops. Condition persists for more than 72 hours.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only with adult supervision.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Water, Alcohol Denature, Cetearyl Alcohol, Glycerin,Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin, Dimethicone, Stearamidopropyl Dimethylamine, Benzyl Alcohol, Farnesol, Panthenol, Zinc Gluconate, Chlorhexidine Digluconate, Citric Acid, Polyquaternium-10, Tocopheryl Acetate.

Other Information

STORAGE AND HANDLING SECTION

Store at 20-25°C (68-77°F)

RECENT MAJOR CHANGES SECTION

  • Uses section
  • Warnings section
  • Stop and ask a doctor if section
  • Keep out of reach of children section
  • Directions section
  • Inactive Ingredient section
  • Package Label. Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57362-468-04

Zylast

Broad Sprectrum

Antimicrobial

Antiseptic

14.79 mL (0.5 fl. oz)

0.5 Lotion K0.5 Lotion K

NDC 57362-468-00

Zylast

Broad Sprectrum

Antimicrobial

Antiseptic

59.159 mL (2 fl. oz)

2 oz Lotion K2 oz Lotion K

NDC 57362-468-03

Zylast

Broad Sprectrum

Antimicrobial

236.59 mL (8 fl. oz)

8 oz Lotion K8 oz Lotion K

NDC 57362-468-05

Zylast

Broad Sprectrum

Antimicrobial

Antiseptic

1000 mL (33.8 fl. oz)

1000 mL lotion K1000 mL lotion K

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046442benzalkonium chloride 0.13 % Topical LotionPSN3
1046442benzalkonium chloride 1.3 MG/ML Topical LotionSCD3
1046442benzalkonium chloride 0.13 % Topical LotionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57362-468-002023-11-12C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K
57362-468-032023-11-12C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K
57362-468-042023-11-12C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K
57362-468-052023-11-12C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K
57362-468-002023-01-30C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K
57362-468-032023-01-30C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K
57362-468-042023-01-30C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K
57362-468-052023-01-30C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K
57362-468-002021-11-03C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K
57362-468-032021-11-03C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K
57362-468-052021-11-03C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K
57362-468-002021-01-29C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K
57362-468-032021-01-29C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K
57362-468-052021-01-29C16284748780-1ba0f9c33-3a32-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion K

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57362-468-00Zylast Antiseptic K59.1 mL in 1 BOTTLE, DISPENSINGLOTION59.13
57362-468-03Zylast Antiseptic K236.6 mL in 1 BOTTLE, PUMPLOTION236.63
57362-468-04Zylast Antiseptic K14.8 mL in 1 TUBELOTION14.83
57362-468-05Zylast Antiseptic K1000 mL in 1 CARTRIDGELOTION10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57362-468ZYLAST ANTISEPTIC K (BENZALKONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]3Current NDC, Legacy NDC, 4 package rows20231113_84766b3b-915c-b604-e053-2a91aa0a672c.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
57362-46857362-468-04, 57362-468-00, 57362-468-03, 57362-468-05

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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 KBENZALKONIUM CHLORIDEInnovative Biodefense84766b3b-915c-b604-e053-2a91aa0a672c2023-01-01WarningsExact identifier
ndc (package): 57362-468-04
ndc (package): 57362-468-00
ndc (package): 57362-468-03
ndc (package): 57362-468-05
ndc (product): 57362-468
ndc11 (package): 57362046800
ndc11 (package): 57362046804
ndc11 (package): 57362046805
ndc11 (package): 57362046803
spl id: 050d6202-97f5-7c43-e063-6294a90a1d74
spl set id: 84766b3b-915c-b604-e053-2a91aa0a672c

Reported adverse events (FAERS/openFDA)#

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