FDA.reportPublic FDA data

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#

ProductHand Sanitizer
Active ingredientALCOHOL
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

Ethanol 62%

OTC - PURPOSE SECTION

Purpose

Hand Sanitizer

INDICATIONS & USAGE SECTION

Uses

  • Sanitizes hands 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
  • 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

  • Receive a small amount of foam into palm of hand
  • Rub thoroughly over all surfaces of both hands, especially 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

Water, DEA-C8-18 perfluoroalkylethyl phosphate, glycereth-2 cocoate, denatonium benzoate, tert-butyl alcohol

OTC - QUESTIONS SECTION

Questions?

Contact Saraya Healthcare USAMon - 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

SARAYAHealthcare USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

- Kills 99.999% of 26 tested pathogens in 15 seconds

- Formulated with emollients to help keep hands soft

- 62% Ethanol formula

Hand Sanitizer Foam

Net Contents: 1250mL (42 fl oz)

Saraya Alc Hand Sanitizer FoamSaraya Alc Hand Sanitizer Foam

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616763ethanol 62 % Topical FoamPSN4
616763ethanol 0.62 ML/ML Topical FoamSCD4
616763ethanol 62 % Topical FoamSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369674100042GTIN-13: 0369674100042
EAN-13: 0369674100042
GTIN-12: 369674100042
UPC-A: 369674100042
GTIN storage (14 digits): 00369674100042		Saraya Alc Hand Sanitizer Foam.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69674-100-01Hand Sanitizer500 mL in 1 BOTTLE, PLASTICLIQUID5004
69674-100-04Hand Sanitizer1250 mL in 1 BOTTLE, PLASTICLIQUID12504
69674-100-07Hand Sanitizer45 mL in 1 BOTTLE, PLASTICLIQUID454

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
69674-10069674-100-01, 69674-100-04, 69674-100-07

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
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE4J55VM509SIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
WATER059QF0KO0RIACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
ALCOHOL3K9958V90MACTIB

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
Hand SanitizerETHANOLSaraya Healthcare30c68860-c7ff-5dbb-e054-00144ff8d46c2026-01-13WarningsExact identifier
ndc (package): 69674-100-07
ndc (package): 69674-100-01
ndc (package): 69674-100-04
ndc (product): 69674-100
ndc11 (package): 69674010007
ndc11 (package): 69674010004
ndc11 (package): 69674010001
spl id: 484af28c-07aa-db5d-e063-6294a90acad3
spl set id: 30c68860-c7ff-5dbb-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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