FDA.reportPublic FDA data

SANI-HANDS ALC ANTIMICROBIAL ALCOHOL GEL WIPES

Manufacturer
Profesional Disposables International, Inc.
Effective date
2011-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:25

Label at a glance#

ProductPDI Sani-Hands ALC Antimicrobial Alcohol Gel Hand Wipes
Active ingredientAlcohol
Label structure9 sections

Indications and uses

Antiseptic. For handwashing to decrease bacteria on the skin; after assisting ill persons; and before contact with a person under medical care or treatment. Apply topically to the skin to help prevent cross-contamination. Recommended for repeated use. Dries in seconds.

Dosage and administration

Tear open packet. Open and unfold towelettes Wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. Be sure to utilize the entire wipe surface. For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with second wipe. Allow to dry. If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe. Sanitize with a second wipe. Discard after sing...

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION


  • Antiseptic.
  • For handwashing to decrease bacteria on the skin; after assisting ill persons; and before contact with a person under medical care or treatment.
  • Apply topically to the skin to help prevent cross-contamination.
  • Recommended for repeated use.
  • Dries in seconds.

Warnings

WARNINGS SECTION

  • Flammable, keep away from fire or flame.
  • For external use only.
  • Do not use in or contact the eyes.
  • Discontinue use if irritation and redness develop. If condition persist for more than 72 hours consult a physician.
  • If swallowed, get medical help or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep this out of reach of children unless under adult supervision.

Directions

SPL UNCLASSIFIED SECTION


  • Tear open packet.
  • Open and unfold towelettes
  • Wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. Be sure to utilize the entire wipe surface.
  • For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with second wipe. Allow to dry.
  • If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe. Sanitize with a second wipe.
  • Discard after single use.

Other information

SPL UNCLASSIFIED SECTION

Lot No. and Expiration Date can be found on packet.

Dosage

DOSAGE & ADMINISTRATION SECTION


For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with second wipe. Discard after single use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Glycerin, Carbomer, Aminometyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate

SPL UNCLASSIFIED SECTION

Professional Disposables International, Inc.
Orangeburg, NY 10962-1376 - USA - 1-800-999-6423

Principal Display Panel - 1000 Packets per Box - Bulk

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sani-Hands(R) ALC
Antimicrobial Alcohol Gel Hand Wipes

An Antiseptic handwash to help prevent cross-contamination.

    Kills 99.99% of Germs

    Contains moisturizing aloe, glycerin and Vitamin E

1000 Packets per Case - Bulk
5 x 8 in (12.7 x 20.3 cm)

Packet Label

Image of Packet LabelImage of Packet Label

Case Label

Image of Box LabelImage of Box Label

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 65.9% by volume

Purpose

OTC - PURPOSE SECTION

Antiseptic

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10819-5001-22025-11-10C16284748780-19d75b9d0-00d3-f424-e053-dadaa90a57ceSANI-HANDS ALC ANTIMICROBIAL ALCOHOL GEL WIPES
10819-5001-22020-01-31C16284748780-19d75b9d0-00d3-f424-e053-dadaa90a57ceSANI-HANDS ALC ANTIMICROBIAL ALCOHOL GEL WIPES

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10819-5001PDI SANI-HANDS ALC ANTIMICROBIAL ALCOHOL GEL HAND WIPES (ALCOHOL) CLOTH [PROFESIONAL DISPOSABLES INTERNATIONAL, INC.]1Legacy NDC20111222_705349b9-35fd-49bf-b8de-832e5e71054e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90M1
AlcoholACTIVE MOIETY3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10819-500110819-5001-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
4340e54d-06a9-a206-e063-6394a90a91d2705349b9-35fd-49bf-b8de-832e5e71054e2025-11-10WarningsExact identifier
spl set id: 705349b9-35fd-49bf-b8de-832e5e71054e

Reported adverse events (FAERS/openFDA)#

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