FDA.reportPublic FDA data

Antimicrobial Foaming Hand Sanitizer

Manufacturer
Saraya Healthcare | Best Sanitizers
Effective date
2026-01-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:28

Label at a glance#

ProductAntimicrobial Foaming Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
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 Ingredient

Benzalkonium Chloride 0.12%

OTC - PURPOSE SECTION

Purpose

Antiseptic Hand Cleanser

INDICATIONS & USAGE SECTION

Uses​

  • Hand wash to help reduce bacteria that potentially can cause diseases
  • Helps to prevent cross-contamination
  • Helps to prevent drying of the skin
  • Recommended for repeated use

WARNINGS SECTION

Warnings

  • For external use only

OTC - WHEN USING SECTION

When using this product

  • Do not use in or near the eyes

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 and forearms
  • Apply appropriate amount to hands, wrists, and forearms
  • Scrub thoroughly for at least 30 seconds (include the fingernails and the cuticles)
  • Rinse with water

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

Benzyl alcohol, cocoamidopropyl betaine, dehydroacetic acid, glycerine, phenoxyethanol, polyethylene-propylene glycol, tetra-sodium EDTA, water

OTC - QUESTIONS SECTION

Questions?

Call Saraya Healthcare USAMon - Fri

9am - 4pm PST at 888.822.1801

SPL UNCLASSIFIED SECTION

Distributed by:

Saraya Healthcare USA

P.O. Box 1360

Penn Valley, CA 95946

866.822.1801

sarayahealthcareusa.com

SARAYAHealthcare USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

– 0.12% Benzalkonium Chloride (BZK) formula

– pH balanced

– Formulated with emollients to help keep skin soft

Antimicrobial Foaming Hand Soap

Net Contents: 1250mL (42 fl oz)

Saraya BZK SoapSaraya BZK Soap

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046310benzalkonium chloride 0.12 % Topical FoamPSN4
1046310benzalkonium chloride 1.2 MG/ML Topical FoamSCD4
1046310benzalkonium chloride 0.12 % Topical FoamSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369674210048GTIN-13: 0369674210048
EAN-13: 0369674210048
GTIN-12: 369674210048
UPC-A: 369674210048
GTIN storage (14 digits): 00369674210048		Saraya BZK Soap.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69674-210-01Antimicrobial Foaming Hand Sanitizer500 mL in 1 BOTTLE, PLASTICLIQUID5004
69674-210-04Antimicrobial Foaming Hand Sanitizer1250 mL in 1 BOTTLE, PLASTICLIQUID12504

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69674-21069674-210-01, 69674-210-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
EDETIC ACID9G34HU7RV0IACT
DEHYDROACETIC ACID2KAG279R6RIACT
BENZYL ALCOHOLLKG8494WBHIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML · Source PDF

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
Antimicrobial Foaming Hand SanitizerBENZALKONIUM CHLORIDESaraya Healthcare3075e40b-41c3-56c6-e054-00144ff88e882026-01-13WarningsExact identifier
ndc (package): 69674-210-01
ndc (package): 69674-210-04
ndc (product): 69674-210
ndc11 (package): 69674021001
ndc11 (package): 69674021004
spl id: 484b006f-aebc-f155-e063-6394a90a4409
spl set id: 3075e40b-41c3-56c6-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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