FDA.reportPublic FDA data

Xtraguard Antibacterial Hand Wipes

Manufacturer
Munchkin Inc.
Effective date
2021-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:35

Label at a glance#

ProductXtraguard Antibacterial Hand Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Storage and handling

Other information Keep away from direct sunlight. Store at room temperature.

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

30 Wipes | 1 wipe: 8 in. x 4 in. (20.3 cm x 10.2 cm)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% - Antimicrobial

OTC - PURPOSE SECTION

Antimicrobial

INDICATIONS & USAGE SECTION

Uses

  • To sanitize hands and decrease bacteria on skin
  • Recommended for repeated use

WARNINGS SECTION

Warnings

For external use only.

When using this product avoid contact with eyes. If contact occurs, wash using water and discontinue use.

OTC - ASK DOCTOR 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.

INSTRUCTIONS FOR USE SECTION

Directions

  • Wet hands thoroughly with wipe.
  • Allow to dry without wiping.
  • Discard wipe in trash after use. Do not flush in toilet.

STORAGE AND HANDLING SECTION

Other information

  • Keep away from direct sunlight. Store at room temperature.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Glycerin, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Tocopheryl Acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 Wipes | NDC: 81725-614-01

Antibacterial Hand Wipes LabelAntibacterial Hand Wipes Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 Wipes | NDC: 81725-614-10

81725-614-1081725-614-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 Wipes | NDC: 81725-614-20

81725-614-2081725-614-20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

90 Wipes | NDC: 81725-614-15

81725-614-1581725-614-15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

90 Wikpes | NDC: 81725-614-25

81725-614-2581725-614-25

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81725-614-012023-01-30C16284748780-1f386c649-c550-0266-e053-dadaa90a7c1ac2269be8-1d8a-2422-e053-2995a90ab6a3
81725-614-102023-01-30C16284748780-1f386c649-c550-0266-e053-dadaa90a7c1ac2269be8-1d8a-2422-e053-2995a90ab6a3
81725-614-152023-01-30C16284748780-1f386c649-c550-0266-e053-dadaa90a7c1ac2269be8-1d8a-2422-e053-2995a90ab6a3
81725-614-202023-01-30C16284748780-1f386c649-c550-0266-e053-dadaa90a7c1ac2269be8-1d8a-2422-e053-2995a90ab6a3
81725-614-252023-01-30C16284748780-1f386c649-c550-0266-e053-dadaa90a7c1ac2269be8-1d8a-2422-e053-2995a90ab6a3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81725-614-01Xtraguard Antibacterial Hand Wipes0.13 g in 1 POUCHSWAB0.131
81725-614-01Xtraguard Antibacterial Hand Wipes30 in 1 BAGSWAB301
81725-614-10Xtraguard Antibacterial Hand Wipes2 in 1 CARTONSWAB21
81725-614-10Xtraguard Antibacterial Hand Wipes30 in 1 BAGSWAB301
81725-614-15Xtraguard Antibacterial Hand Wipes3 in 1 CARTONSWAB31
81725-614-15Xtraguard Antibacterial Hand Wipes30 in 1 BAGSWAB301
81725-614-20Xtraguard Antibacterial Hand Wipes30 in 1 BAGSWAB301
81725-614-20Xtraguard Antibacterial Hand Wipes2 in 1 CARTONSWAB21
81725-614-25Xtraguard Antibacterial Hand Wipes30 in 1 BAGSWAB301
81725-614-25Xtraguard Antibacterial Hand Wipes3 in 1 CARTONSWAB31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81725-614XTRAGUARD ANTIBACTERIAL HAND WIPES (BENZALKONIUM CHLORIDE) SWAB [MUNCHKIN INC.]1Legacy NDC, 10 package rows20210528_c2269be8-1d8a-2422-e053-2995a90ab6a3.zip

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
81725-61481725-614-10, 81725-614-15, 81725-614-20, 81725-614-25, 81725-614-01
69821-001

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
PHENOXYETHANOLHIE492ZZ3TIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT

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
c2269be8-1d8b-2422-e053-2995a90ab6a3c2269be8-1d8a-2422-e053-2995a90ab6a32021-05-12WarningsExact identifier
spl id: c2269be8-1d8b-2422-e053-2995a90ab6a3
spl set id: c2269be8-1d8a-2422-e053-2995a90ab6a3

Reported adverse events (FAERS/openFDA)#

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