FDA.reportPublic FDA data

Antibacterial Bathing

Manufacturer
Cardinal Health, Inc.
Effective date
2025-01-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:52:07

Label at a glance#

ProductAntibacterial Bathing
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Indications and uses

to decrease bacteria on skin

Dosage and administration

Cloths can be used at room temperature or heated in a wipes warmer for extra comfort. Warming Instructions: single warming session at temperatures not to exceed 52˚C (125˚F) and for a maximum of 200 hours. Discard wipes that have been exposed to warming temperatures exceeding 52˚C (125˚F) or stored longer than 200 hours in the warmer. Bathing Instructions: Remove one cloth at a time to clean each area in the follo...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • to decrease bacteria on skin

Warnings

WARNINGS SECTION

For external use only

Do not heat sealed package in microwave

Ask a doctor before you use if you have:

OTC - ASK DOCTOR SECTION

  • Deep puncture wounds
  • Animal bites
  • Serious burns

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • In case of accidental ingestion seek medical help or contact a Poison Control Center immediately.
  • Gloves diminish sensitivity to heat
  • Closely monitor heat level with infants, unresponsive or skin sensitive individuals

Do not use

OTC - DO NOT USE SECTION

  • In the eye
  • Longer than 1 week unless directed by a physician
  • Over raw surfaces or blistered areas

Directions

DOSAGE & ADMINISTRATION SECTION

  • Cloths can be used at room temperature or heated in a wipes warmer for extra comfort. Warming Instructions:
  • single warming session at temperatures not to exceed 52˚C (125˚F) and
  • for a maximum of 200 hours.
  • Discard wipes that have been exposed to warming temperatures exceeding 52˚C (125˚F) or
  • stored longer than 200 hours in the warmer. Bathing Instructions:
  • Remove one cloth at a time to clean each area in the following order: 1. Neck & facial area; 2. Front torso; 3. Right arm; 4. Left arm; 5. Right leg; 6. Left leg; 7. Back torso; 8. Buttocks & perineal area
  • Allow skin to dry
  • Dispose of cloth in waste receptacle
  • Do not flush cloths in toilet

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Phenoxyethanol, Sodium Benzoate, Aloe Barbadensis Leaf Extract, Myristamidopropyl PG-Dimonium Chloride Phosphate, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Citric Acid, Disodium EDTA, Allantoin.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN5
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD5
1038558benzalkonium chloride 0.13 % Topical ClothSY5
1038558benzalkonium chloride 0.13 % Topical SwabSY5
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY5
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY5
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63517-210-22Antibacterial Bathing1 in 1 POUCHCLOTH15
63517-210-22Antibacterial Bathing8 in 1 PACKETCLOTH85

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63517-210ANTIBACTERIAL BATHING (BENZALKONIUM CHLORIDE) CLOTH [CARDINAL HEALTH, INC.]5Current NDC, Legacy NDC, 2 package rows20250112_586463f3-d117-47ae-bbab-f7caff1f5fa8.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63517-21063517-210-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM BENZOATEOJ245FE5EUIACT
ALOE VERA LEAFZY81Z83H0XIACT
MYRISTAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATEE4821CQM1IIACT
LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE5Q87K461JOIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
ALLANTOIN344S277G0ZIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT

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
Antibacterial BathingBENZALKONIUM CHLORIDECardinal Health, Inc.586463f3-d117-47ae-bbab-f7caff1f5fa82025-01-06WarningsExact identifier
ndc (package): 63517-210-22
ndc (product): 63517-210
ndc11 (package): 63517021022
spl id: 2b0d5a9c-7a58-ccfd-e063-6394a90ae938
spl set id: 586463f3-d117-47ae-bbab-f7caff1f5fa8

Reported adverse events (FAERS/openFDA)#

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