FDA.reportPublic FDA data

Sipa HAND SANITIZING WIPES

Manufacturer
Sipa Holdings USA, Inc.
Effective date
2025-12-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:28:18

Label at a glance#

ProductSipa HAND SANITIZING WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Benzalkonium Chloride 0.13% w/w

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Use

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

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

· Wet hands thoroughly with product and allow to dry.

· Discard wipes in trash receptacle after use. Do not flush.

· Children under 6 years of age should be supervised when using this product.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Glycerin, Aloe Barbadensis Leaf Juice, Decyl Glucoside, Phenoxyethanol, Fragrance.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50PCS
NDC: 85137-001-01

50 Label50 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 WIPES
NDC: 85137-001-02

100 Label100 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250PCS
NDC: 85137-001-03

250 Label250 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500PCS
NDC: 85137-001-04

500 Label500 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN3
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD3
1038558benzalkonium chloride 0.13 % Topical ClothSY3
1038558benzalkonium chloride 0.13 % Topical SwabSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY3
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130040232498732GTIN-13: 0040232498732
EAN-13: 0040232498732
GTIN-12: 040232498732
UPC-A: 040232498732
GTIN storage (14 digits): 00040232498732		100 WIPES Label.jpg
BarcodeEAN-130040232528927GTIN-13: 0040232528927
EAN-13: 0040232528927
GTIN-12: 040232528927
UPC-A: 040232528927
GTIN storage (14 digits): 00040232528927		250PCS Label.jpg
BarcodeEAN-130040232528934GTIN-13: 0040232528934
EAN-13: 0040232528934
GTIN-12: 040232528934
UPC-A: 040232528934
GTIN storage (14 digits): 00040232528934		500PCS Label.jpg
BarcodeEAN-130040232528965GTIN-13: 0040232528965
EAN-13: 0040232528965
GTIN-12: 040232528965
UPC-A: 040232528965
GTIN storage (14 digits): 00040232528965		50PCS Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85137-001-01Sipa HAND SANITIZING WIPES0.005265 g in 1 PATCHCLOTH0.0052653
85137-001-01Sipa HAND SANITIZING WIPES50 in 1 BAGCLOTH503
85137-001-02Sipa HAND SANITIZING WIPES0.00393 g in 1 PATCHCLOTH0.003933
85137-001-02Sipa HAND SANITIZING WIPES100 in 1 CANISTERCLOTH1003
85137-001-03Sipa HAND SANITIZING WIPES0.00393 g in 1 PATCHCLOTH0.003933
85137-001-03Sipa HAND SANITIZING WIPES250 in 1 CANISTERCLOTH2503
85137-001-04Sipa HAND SANITIZING WIPES500 in 1 CANISTERCLOTH5003
85137-001-04Sipa HAND SANITIZING WIPES0.00393 g in 1 PATCHCLOTH0.003933

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
85137-00185137-001-01, 85137-001-02, 85137-001-03, 85137-001-04

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
DECYL GLUCOSIDEZ17H97EA6YIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT

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
Sipa HAND SANITIZING WIPESBENZALKONIUM CHLORIDESipa Holdings USA, Inc.2c47f1a8-4416-fd21-e063-6394a90ae1672025-12-23WarningsExact identifier
ndc (package): 85137-001-02
ndc (package): 85137-001-03
ndc (package): 85137-001-04
ndc (package): 85137-001-01
ndc (product): 85137-001
ndc11 (package): 85137000103
ndc11 (package): 85137000102
ndc11 (package): 85137000101
ndc11 (package): 85137000104
spl id: 46966e2c-fb6f-68b2-e063-6394a90a17e1
spl set id: 2c47f1a8-4416-fd21-e063-6394a90ae167

Reported adverse events (FAERS/openFDA)#

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