FDA.reportPublic FDA data

I.C. Hand Sanitizer

Manufacturer
R&R Lotion, Inc.
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:28:09

Label at a glance#

ProductI.C. Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

Pump a small amount of foam into palm of hand Rub thoroughly over all surfaces of both hands Rub hands together briskly until dry.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this productavoid contact with eyes. If contact with eyes, flush with water.

OTC - STOP USE SECTION

Stop use and ask a doctorif 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Pump a small amount of foam into palm of hand
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together briskly until dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

DI Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid

Samples or Comments?

OTC - QUESTIONS SECTION

Call (480) 443-9255 or visit RRlotion.com

PRINCIPAL DISPLAY PANEL - 591 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

I.C. ®
Foaming
Hand
Sanitizer

R&R LOTION
USA

Kills 99.99%
of Germs

20 FL OZ. (591ML) ℮

Principal Display Panel - 591 ML Bottle Label
Principal Display Panel - 591 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN6
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD6
1038799benzalkonium chloride 0.1 % Topical FoamSY6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130666080847821GTIN-13: 0666080847821
EAN-13: 0666080847821
GTIN-12: 666080847821
UPC-A: 666080847821
GTIN storage (14 digits): 00666080847821		sanitizer-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59555-401-112025-12-22C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-122025-12-22C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-132025-12-22C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-112025-01-30C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-122025-01-30C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-132025-01-30C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-112022-02-14C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-122022-02-14C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-132022-02-14C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-112022-01-28C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-122022-01-28C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-132022-01-28C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-112020-04-30C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-122020-04-30C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-132020-04-30C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-112019-11-27C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-122019-11-27C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-132019-11-27C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59555-401-04I.C. Hand Sanitizer59 mL in 1 BOTTLE, SPRAYAEROSOL, FOAM596
59555-401-11I.C. Hand Sanitizer3785 mL in 1 BOTTLE, PUMPAEROSOL, FOAM37856
59555-401-12I.C. Hand Sanitizer591 mL in 1 BOTTLE, PUMPAEROSOL, FOAM5916
59555-401-13I.C. Hand Sanitizer50 mL in 1 BOTTLE, PUMPAEROSOL, FOAM506

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W71
BenzalkoniumACTIVE MOIETY7N6JUD5X6Y1
Cetrimonium ChlorideINACTIVE INGREDIENTUC9PE95IBP1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QP1
Dihydroxyethyl Cocamine OxideINACTIVE INGREDIENT8AR51R3BL51
Glycereth-17 CocoateINACTIVE INGREDIENT3057VPT0KC1
Laurtrimonium ChlorideINACTIVE INGREDIENTA81MSI0FIC1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59555-40159555-401-04, 59555-401-12, 59555-401-11, 59555-401-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT
GLYCERETH-17 COCOATE3057VPT0KCIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route+dosage form
5 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
I.C. Hand SanitizerBENZALKONIUM CHLORIDER&R Lotion, Inc.5361bb71-cc84-4a76-a0cf-2259a615baa42025-12-16WarningsExact identifier
ndc (package): 59555-401-13
ndc (package): 59555-401-11
ndc (package): 59555-401-12
ndc (package): 59555-401-04
ndc (product): 59555-401
ndc11 (package): 59555040112
ndc11 (package): 59555040104
ndc11 (package): 59555040113
ndc11 (package): 59555040111
spl id: 4615b07d-430b-4729-e063-6394a90a064b
spl set id: 5361bb71-cc84-4a76-a0cf-2259a615baa4

Reported adverse events (FAERS/openFDA)#

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