FDA.reportPublic FDA data

Sani Luxe ® Hand Sanitizer Gel with Alcohol

Manufacturer
Celeste Industries Corporation
Effective date
2024-07-08
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 00:14:50

Label at a glance#

ProductSani Luxe Hand Sanitizer with Alcohol
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

Children under 6 years of age should be supervised when using this product Place enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry

Storage and handling

Store below 110°F (43°C) May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62.5%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • For external use only.
  • Flammable. Keep away from open flame and sources of heat.

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 - WHEN USING SECTION

  • When using this product, avoid contact with eyes. In case of eye contact, flush eyes with water.
  • If swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Children under 6 years of age should be supervised when using this product
  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly until dry

Other information

STORAGE AND HANDLING SECTION

  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, PEG-4 Diheptanoate, Acrylates/C10-30 Alkyl Acrylate crosspolymer, Fragrance, Aminomethyl Propanol

May contain hydroxypropylcellulose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sani Luxe ®

HAND SANITIZER GEL

with Alcohol

  • Requires no water or towels.
  • Apply small amount to hands

    and rub until dry.

Kills 99%

of germs

on contact

Caution: Use on hands only.

284ml e

PRINCIPAL DISPLAY PANEL - 284 ml Bottle LabelPRINCIPAL DISPLAY PANEL - 284 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1860080ethanol 62.5 % Topical GelPSN13
1860080ethanol 0.625 ML/ML Topical GelSCD13
1860080ethanol 62.5 % Topical GelSY13

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71489-007-012024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-022024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-032024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-042024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-052024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-062024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-072024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-082024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-092024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-102024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-112024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-122024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-132024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-142024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-152024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol
71489-007-162024-01-30C16284748780-11030e365-0975-111a-e063-dadaa90a10e2Sani Luxe ® Hand Sanitizer Gel with Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71489-007-01Sani Luxe Hand Sanitizer with Alcohol284 mL in 1 BOTTLE, PUMPGEL28413
71489-007-02Sani Luxe Hand Sanitizer with Alcohol177 mL in 1 BOTTLEGEL17713
71489-007-03Sani Luxe Hand Sanitizer with Alcohol59 mL in 1 BOTTLE, PUMPGEL5913
71489-007-04Sani Luxe Hand Sanitizer with Alcohol237 mL in 1 BOTTLE, PUMPGEL23713
71489-007-05Sani Luxe Hand Sanitizer with Alcohol355 mL in 1 BOTTLE, PUMPGEL35513
71489-007-06Sani Luxe Hand Sanitizer with Alcohol3785 mL in 1 BOTTLEGEL378513
71489-007-07Sani Luxe Hand Sanitizer with Alcohol59 mL in 1 BOTTLEGEL5913
71489-007-08Sani Luxe Hand Sanitizer with Alcohol177 mL in 1 BOTTLE, PUMPGEL17713
71489-007-09Sani Luxe Hand Sanitizer with Alcohol237 mL in 1 BOTTLEGEL23713
71489-007-10Sani Luxe Hand Sanitizer with Alcohol284 mL in 1 BOTTLEGEL28413
71489-007-11Sani Luxe Hand Sanitizer with Alcohol355 mL in 1 BOTTLEGEL35513
71489-007-12Sani Luxe Hand Sanitizer with Alcohol3785 mL in 1 BOTTLE, PUMPGEL378513
71489-007-13Sani Luxe Hand Sanitizer with Alcohol946 mL in 1 BOTTLE, PUMPGEL94613
71489-007-14Sani Luxe Hand Sanitizer with Alcohol946 mL in 1 BOTTLEGEL94613
71489-007-15Sani Luxe Hand Sanitizer with Alcohol530 mL in 1 BOTTLEGEL53013
71489-007-16Sani Luxe Hand Sanitizer with Alcohol530 mL in 1 BOTTLE, PUMPGEL53013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71489-007SANI LUXE HAND SANITIZER WITH ALCOHOL (ALCOHOL) GEL [CELESTE INDUSTRIES CORPORATION]13Current NDC, Legacy NDC, 16 package rows20240709_1a259dcf-4d82-4a42-be1f-0e557e0940bd.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
71489-00771489-007-01, 71489-007-02, 71489-007-03, 71489-007-04, 71489-007-05, 71489-007-06, 71489-007-07, 71489-007-08, 71489-007-09, 71489-007-10, 71489-007-11, 71489-007-12, 71489-007-13, 71489-007-14, 71489-007-15, 71489-007-16

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
WATER059QF0KO0RIACT
PEG-4 DIHEPTANOATE2DQ7O61VHJIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
ALCOHOL3K9958V90MACTIB

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 Luxe Hand Sanitizer with AlcoholALCOHOLCeleste Industries Corporation1a259dcf-4d82-4a42-be1f-0e557e0940bd2024-07-08WarningsExact identifier
ndc (package): 71489-007-13
ndc (package): 71489-007-01
ndc (package): 71489-007-06
ndc (package): 71489-007-16
ndc (package): 71489-007-14
ndc (package): 71489-007-08
ndc (package): 71489-007-03
ndc (package): 71489-007-15
ndc (package): 71489-007-10
ndc (package): 71489-007-11
ndc (package): 71489-007-02
ndc (package): 71489-007-05
ndc (package): 71489-007-12
ndc (package): 71489-007-07
ndc (package): 71489-007-09
ndc (package): 71489-007-04
ndc (product): 71489-007
ndc11 (package): 71489000701
ndc11 (package): 71489000710
ndc11 (package): 71489000716
ndc11 (package): 71489000715
ndc11 (package): 71489000714
ndc11 (package): 71489000702
ndc11 (package): 71489000707
ndc11 (package): 71489000708
ndc11 (package): 71489000711
ndc11 (package): 71489000704
ndc11 (package): 71489000703
ndc11 (package): 71489000713
ndc11 (package): 71489000709
ndc11 (package): 71489000712
ndc11 (package): 71489000706
ndc11 (package): 71489000705
spl id: 1cc045e7-0007-22bc-e063-6394a90a11fa
spl set id: 1a259dcf-4d82-4a42-be1f-0e557e0940bd

Reported adverse events (FAERS/openFDA)#

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