FDA.reportPublic FDA data

PDI Sani-Hands

Manufacturer
Professional Disposables International, Inc.
Effective date
2024-08-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:17:34

Label at a glance#

ProductPDI Sani-Hands Instant Hand Sanitizing Wipes
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

To decrease bacteria on the skin

Dosage and administration

- To start feed: Remove cover and discard seal from container. From center of toweled roll, pull up wipe corner; tear off first wipe for use. Twist next wipe into a point and thread through the hole in the container cover. Pull through about one inch. Replace cover. Pull out wipes as needed and snap off at a 90 o angle. Keep cap closed to prevent evaporation. - Wipe hands, fingers, interdigital areas and wrists th...

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable. Keep away from fire or flame.
  • When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
  • Do not use in or contact with eyes.
  • Stop use and ask a doctor if irritation or redness develops and continues for more than 72 hours
  • Discontinue use if irritation and redness develop. If condition for more persists for more than 72 hours, consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, glycerin, propylene glycol, purified water, tocopheryl acetate

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% by volume

Purpose

OTC - PURPOSE SECTION

Antiseptic

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children unless under adult supervision.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

- To start feed: Remove cover and discard seal from container. From center of toweled roll, pull up wipe corner; tear off first wipe for use. Twist next wipe into a point and thread through the hole in the container cover. Pull through about one inch. Replace cover. Pull out wipes as needed and snap off at a 90 o angle. Keep cap closed to prevent evaporation.

- Wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. Be sure to utilize the entire wipe surface. 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

OTHER SAFETY INFORMATION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

front 135 ct

front 135front 135

back 135ct

back 135back 135

front 220 ct

frontfront

back 200 ct

backback

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251416ethanol 65.9 % Medicated PadPSN5
1251416ethanol 0.659 ML/ML Medicated PadSCD5
1251416ethanol 65.9 % Medicated PadSY5
1251416ethanol 65.9 % Topical ClothSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10819-3917-1PDI Sani-HandsInstant Hand Sanitizing Wipes500 mL in 1 CANISTERCLOTH5005
10819-3917-2PDI Sani-HandsInstant Hand Sanitizing Wipes814 mL in 1 CANISTERCLOTH8145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10819-3917PDI SANI-HANDS INSTANT HAND SANITIZING WIPES (ALCOHOL) CLOTH [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]5Current NDC, Legacy NDC, 2 package rows20240822_d43b7f97-4ecb-4b81-a975-c02f516dcaef.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90M1
AlcoholACTIVE MOIETY3K9958V90M1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
WATERINACTIVE INGREDIENT059QF0KO0R1

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
10819-391710819-3917-2, 10819-3917-1

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
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
9 equally ranked IID candidates

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
PDI Sani-Hands Instant Hand Sanitizing WipesALCOHOLProfessional Disposables International, Inc.d43b7f97-4ecb-4b81-a975-c02f516dcaef2024-08-20WarningsExact identifier
ndc (package): 10819-3917-2
ndc (package): 10819-3917-1
ndc (product): 10819-3917
ndc11 (package): 10819391702
ndc11 (package): 10819391701
spl id: 202399d0-b2ff-d1fc-e063-6394a90a3fd1
spl set id: d43b7f97-4ecb-4b81-a975-c02f516dcaef

Reported adverse events (FAERS/openFDA)#

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