FDA.reportPublic FDA data

Healthcare Personnel Handwash

Manufacturer
Saraya Healthcare | Best Sanitizers
Effective date
2019-01-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:03

Label at a glance#

ProductHealthcare Personnel Handwash
Active ingredientBENZALKONIUM CHLORIDE, ALCOHOL
Label structure12 sections

Storage and handling

Other information Store in a cool, dry place below 104°F

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Ethanol 65.9%

Benzalkonium Chloride 0.10%

OTC - PURPOSE SECTION

Purpose

Antiseptic

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • Sterilizes hands to help reduce bacteria that accidentally can cause diseases
  • Helps to prevent cross-contamination
  • Helps prevent drying of the skin
  • Recommended for repeated use

WARNINGS SECTION

Warnings

  • For external use only
  • Flammable, keep away from fire or flame

OTC - WHEN USING SECTION

When using this product

  • Do not use in or near eyes
  • Use in a well-ventilated area
  • Discontinue use if irritation and redness develop

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

In case of accidental ingestion, seek medical attention or contact a poison control center immediately

DOSAGE & ADMINISTRATION SECTION

Directions

  • Wet hands thoroughly with spray, covering entire surface of hands, especially the fingernails and cuticles
  • Rub hands together until dry

STORAGE AND HANDLING SECTION

Other information

  • Store in a cool, dry place below 104°F

INACTIVE INGREDIENT SECTION

Inactive ingredients

Glycerin, water

OTC - QUESTIONS SECTION

Questions?

Contact Saraya Healthcare USA Mon - Fri 9am-4pm PST at 866.822.1801

SPL UNCLASSIFIED SECTION

Distributed by:

Saraya Healthcare USA

P.O. Box 1360

Penn Valley, CA 95946

866.822.1801

sarayahealthcareusa.com

SARAYA Healthcare USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healthcare Personnel Handwash

– Ethanol/BZK formula

– Atomized mist saturates cuticles and crevices of hands and fingers

– Formulated with emollients to help keep hands soft

Net Contents: 1000mL (34 fl oz)

Saraya Hand Sanitizer Spray Alc BZKSaraya Hand Sanitizer Spray Alc BZK

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1598027ethanol 62 % / benzalkonium chloride 0.1 % Topical SprayPSN2
1598027benzalkonium chloride 1 MG/ML / ethanol 0.62 ML/ML Topical SpraySCD2
1598027benzalkonium chloride 0.1 % / ethanol 62 % Topical SpraySY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69674-110-012022-01-28C16284748780-1d6a99b39-eb45-a426-e053-dadaa90af4c2SARAYA HEALTHCARE PERSONNEL HANDWASH
69674-110-042022-01-28C16284748780-1d6a99b39-eb45-a426-e053-dadaa90af4c2SARAYA HEALTHCARE PERSONNEL HANDWASH
69674-110-072022-01-28C16284748780-1d6a99b39-eb45-a426-e053-dadaa90af4c2SARAYA HEALTHCARE PERSONNEL HANDWASH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69674-110-01Healthcare Personnel Handwash1000 mL in 1 BOTTLE, PLASTICLIQUID10002
69674-110-04Healthcare Personnel Handwash1000 mL in 1 BAGLIQUID10002
69674-110-07Healthcare Personnel Handwash45 mL in 1 BOTTLE, PLASTICLIQUID452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69674-110HEALTHCARE PERSONNEL HANDWASH (ETHANOL, BENZALKONIUM CHLORIDE) LIQUID [SARAYA HEALTHCARE]2Legacy NDC, 3 package rows20190103_30c6ff5a-fbed-45c4-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69674-11069674-110-01, 69674-110-07, 69674-110-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT

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
7e836a1d-f589-5db0-e053-2991aa0aa12f30c6ff5a-fbed-45c4-e054-00144ff88e882019-01-02WarningsExact identifier
spl id: 7e836a1d-f589-5db0-e053-2991aa0aa12f
spl set id: 30c6ff5a-fbed-45c4-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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