FDA.reportPublic FDA data

Sani Luxe

Manufacturer
Celeste Industries Corporation
Effective date
2024-07-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:14:53

Label at a glance#

ProductSani Luxe
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

For hand sanitizing to decrease bacteria on the skin Recommended for repeated use

Dosage and administration

Apply to hands Allow skin to dry without wiping

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol (ethanol) 70%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use

Warning

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of eye contact,
flush eyes with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops, or if
condition persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply to hands
  • Allow skin to dry without wiping

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cocamindopropyl PG-Dimonium, Chloride Phosphate, Linear alcohol ethoxylate, Fragrance.

SPL UNCLASSIFIED SECTION

Expires:
DDMMMYYYY

Manufactured by:
Celeste Industries Corporation
Easton, Maryland 21601 • USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SaniLuxe® HAND SANITIZER WIPE 1.75 mL Antibacterial Hand Sanitizer Kills 99.9% of germs Open packet Unfold cloth Wipe surfaces Phone • Computer • Communications Equipment • HandsSaniLuxe® HAND SANITIZER WIPE 1.75 mL Antibacterial Hand Sanitizer Kills 99.9% of germs Open packet Unfold cloth Wipe surfaces Phone • Computer • Communications Equipment • Hands

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489307ethanol 70 % Medicated PadPSN4
1489307ethanol 0.7 ML/ML Medicated PadSCD4
1489307ethanol 70 % Medicated PadSY4
1489307ethanol 70 % Medicated WipesSY4
1489307ethyl alcohol 70 % ClothSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71489-009-012024-01-30C16284748780-11030e365-13f0-111a-e063-dadaa90a10e2Sani Luxe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71489-009-01Sani Luxe1.75 mL in 1 PACKETCLOTH1.754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71489-009SANI LUXE (ALCOHOL) CLOTH [CELESTE INDUSTRIES CORPORATION]4Current NDC, Legacy NDC, 1 package rows20240709_ba0f4e72-c50a-41c0-e053-2995a90aeee1.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71489-00971489-009-01

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
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
C9-11 PARETH-6KCE0V8JT7WIACT

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
Sani LuxeALCOHOLCeleste Industries Corporationba0f4e72-c50a-41c0-e053-2995a90aeee12024-07-08WarningsExact identifier
ndc (package): 71489-009-01
ndc (product): 71489-009
ndc11 (package): 71489000901
spl id: 1cc23869-b53e-2a76-e063-6394a90a47cc
spl set id: ba0f4e72-c50a-41c0-e053-2995a90aeee1

Reported adverse events (FAERS/openFDA)#

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