FDA.reportPublic FDA data

Industrial Foaming Hand Sanitizer

Manufacturer
R & R Lotion, Inc
Effective date
2015-12-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:26

Label at a glance#

ProductIndustrial Foaming 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 product avoid contact with eyes. If contact with eyes, flush with water.

OTC - STOP USE 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.

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

Questions or Comments

OTC - QUESTIONS SECTION

Call (480) 443-9255

PRINCIPAL DISPLAY PANEL - 591 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STRENGTH

INDUSTRIAL
FOAMING SANITIZER

KILLS GERMS

20 FL. OZ. (591ML) e

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 FoamPSN1
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD1
1038799benzalkonium chloride 0.1 % Topical FoamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59555-402-112020-01-31C16284748780-19d75b9d1-0342-f424-e053-dadaa90a57ceIndustrial Foaming Hand Sanitizer
59555-402-122020-01-31C16284748780-19d75b9d1-0342-f424-e053-dadaa90a57ceIndustrial Foaming Hand Sanitizer
59555-402-132020-01-31C16284748780-19d75b9d1-0342-f424-e053-dadaa90a57ceIndustrial Foaming Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59555-402-11Industrial Foaming Hand Sanitizer3785 mL in 1 BOTTLE, PUMPAEROSOL, FOAM37851
59555-402-12Industrial Foaming Hand Sanitizer591 mL in 1 BOTTLE, PLASTICAEROSOL, FOAM5911
59555-402-13Industrial Foaming Hand Sanitizer50 mL in 1 BOTTLE, PUMPAEROSOL, FOAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59555-402INDUSTRIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [R & R LOTION, INC]1Legacy NDC, 3 package rows20151221_e9db74b4-337a-4ae0-80bd-3f6014c34890.zip

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
59555-40259555-402-12, 59555-402-11, 59555-402-13

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
Benzalkonium ChlorideF5UM2KM3W7ACTIB
Water059QF0KO0RIACT
Cetrimonium ChlorideUC9PE95IBPIACT
Laurtrimonium ChlorideA81MSI0FICIACT
Dihydroxyethyl Cocamine Oxide8AR51R3BL5IACT
Glycereth-17 Cocoate3057VPT0KCIACT
Citric Acid Monohydrate2968PHW8QPIACT

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
8b10430b-1e2a-4d05-bc0a-0d377cc51c88e9db74b4-337a-4ae0-80bd-3f6014c348902015-12-04WarningsExact identifier
spl id: 8b10430b-1e2a-4d05-bc0a-0d377cc51c88
spl set id: e9db74b4-337a-4ae0-80bd-3f6014c34890

Reported adverse events (FAERS/openFDA)#

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