FDA.reportPublic FDA data

I.C. Antibacterial Hand Cleaner with Pumice

Manufacturer
R & R Lotion, Inc
Effective date
2021-10-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:44:40

Label at a glance#

ProductI.C. Antibacterial Hand Cleaner with Pumice
Active ingredientBenzalkonium Chloride
Label structure9 sections

Indications and uses

For hand washing to decrease bacteria on the skin

Dosage and administration

Pump into DRY hands. Lather vigorously for at least 15 seconds Rinse and dry throughly

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes. In case of eye contact, flush with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Pump into DRY hands.
  • Lather vigorously for at least 15 seconds
  • Rinse and dry throughly

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cocamide MEA, Carbopol SF-2, Xanthan Gum, Sodium Laureth Sulfate, Cocamidopropyl Betaine, TEA Lauryl Sulfate, Triethanolamine 99, Geogard Ultra, Sodium Chloride, Citric Acid, Sodium Hydroxide, Pumice

Samples & Comments?

OTC - QUESTIONS SECTION

Call (480) 443-9255

PRINCIPAL DISPLAY PANEL - 946 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

I.C.®
Antibacterial
Hand
Cleaner
with Pumice

R&R LOTION
USA

Kills Germs

32oz. (946ml) ℮

PRINCIPAL DISPLAY PANEL - 946 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 946 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59555-501-042025-01-30C16284748780-12cef2736-8638-d83d-e063-dadaa90ab31fI.C. ® Antibacterial Hand Cleaner with Pumice
59555-501-082025-01-30C16284748780-12cef2736-8638-d83d-e063-dadaa90ab31fI.C. ® Antibacterial Hand Cleaner with Pumice
59555-501-092025-01-30C16284748780-12cef2736-8638-d83d-e063-dadaa90ab31fI.C. ® Antibacterial Hand Cleaner with Pumice
59555-501-102025-01-30C16284748780-12cef2736-8638-d83d-e063-dadaa90ab31fI.C. ® Antibacterial Hand Cleaner with Pumice
59555-501-112025-01-30C16284748780-12cef2736-8638-d83d-e063-dadaa90ab31fI.C. ® Antibacterial Hand Cleaner with Pumice

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59555-501-04I.C. Antibacterial Hand Cleaner with Pumice59 mL in 1 BOTTLE, PUMPSOAP591
59555-501-08I.C. Antibacterial Hand Cleaner with Pumice236 mL in 1 BOTTLE, DISPENSINGSOAP2361
59555-501-09I.C. Antibacterial Hand Cleaner with Pumice473 mL in 1 BOTTLE, DISPENSINGSOAP4731
59555-501-10I.C. Antibacterial Hand Cleaner with Pumice946 mL in 1 BOTTLE, PUMPSOAP9461
59555-501-11I.C. Antibacterial Hand Cleaner with Pumice3780 mL in 1 BOTTLE, DISPENSINGSOAP37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59555-501I.C. ANTIBACTERIAL HAND CLEANER WITH PUMICE (BENZALKONIUM CHLORIDE) SOAP [R & R LOTION, INC]1Legacy NDC, 5 package rows20211103_847dd5e3-d16a-4ea7-9898-aa48b0137f30.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59555-50159555-501-04, 59555-501-08, 59555-501-09, 59555-501-10, 59555-501-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzalkonium ChlorideF5UM2KM3W7ACTIB
water059QF0KO0RIACT
Triethanolamine Lauryl SulfateE8458C1KAAIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
Cocamidopropyl Betaine5OCF3O11KXIACT
COCO MONOETHANOLAMIDEC80684146DIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLUCONOLACTONEWQ29KQ9POTIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM HYDROXIDE55X04QC32IIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT
TROLAMINE9O3K93S3TKIACT
Xanthan GumTTV12P4NEEIACT

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
a9749b81-3888-4f22-a522-69c693aa165e847dd5e3-d16a-4ea7-9898-aa48b0137f302021-10-07WarningsExact identifier
spl id: a9749b81-3888-4f22-a522-69c693aa165e
spl set id: 847dd5e3-d16a-4ea7-9898-aa48b0137f30

Reported adverse events (FAERS/openFDA)#

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