FDA.reportPublic FDA data

Industrial Strength Waterless Hand Cleaner

Manufacturer
R & R Lotion, Inc
Effective date
2021-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:27

Label at a glance#

ProductIndustrial Strength Waterless Hand Cleaner
Active ingredientBenzalkonium Chloride
Label structure9 sections

Indications and uses

A waterless hand cleaner that removes dirt and grime while killing germs, sanitizing, & remoisturizing your hands.

Dosage and administration

Rub hand cleaner into dry hands until dirt or grease is dissolved & wipe dry with towel.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

A waterless hand cleaner that removes dirt and grime while killing germs, sanitizing, & remoisturizing your hands.

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

  • When using this product, aviod contact with eyes
  • In case of eye contact, flush with water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children, except under adult supervision
  • If swallowed, get medical help
  • Discontinue use if skin irritation or redness develops

Directions

DOSAGE & ADMINISTRATION SECTION

Rub hand cleaner into dry hands until dirt or grease is dissolved & wipe dry with towel.

Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Arlacel 165, Incroquat Behenyl TMS, Caprylic/Capric Triglyceride, Glycerin 99%, Shea Butter, Sunflower Butter, Floraesters K-20W, Lanette 16, Geogard Ultra, Xanthan Gum, Disodium EDTA, Pumice, Succulents (Jojoba, Blue Agave, Aloe Vera), Extracts (Acai, Aloe Whole Leaf, Blueberry, Cranberry, Grape Seed, Green Coffee, Green Tea, Pomegranate, Raspberry Fruit & Strawberry), Vitamin A & D, Vitamin E Acetate.

Questions or Comments?

OTC - QUESTIONS SECTION

Call (480) 443-9255

PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CRÈME

STRENGTH
INDUSTRIAL
WATERLESS
HAND CLEANER

KILLS GERMS

8 FL. OZ. (236ML) e

PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046442benzalkonium chloride 0.13 % Topical LotionPSN2
1046442benzalkonium chloride 1.3 MG/ML Topical LotionSCD2
1046442benzalkonium chloride 0.13 % Topical LotionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59555-302-032025-01-30C16284748780-12cef2736-7516-d83d-e063-dadaa90ab31fIndustrial Strength Waterless Hand Cleaner
59555-302-042025-01-30C16284748780-12cef2736-7516-d83d-e063-dadaa90ab31fIndustrial Strength Waterless Hand Cleaner
59555-302-082025-01-30C16284748780-12cef2736-7516-d83d-e063-dadaa90ab31fIndustrial Strength Waterless Hand Cleaner
59555-302-092025-01-30C16284748780-12cef2736-7516-d83d-e063-dadaa90ab31fIndustrial Strength Waterless Hand Cleaner
59555-302-102025-01-30C16284748780-12cef2736-7516-d83d-e063-dadaa90ab31fIndustrial Strength Waterless Hand Cleaner
59555-302-112025-01-30C16284748780-12cef2736-7516-d83d-e063-dadaa90ab31fIndustrial Strength Waterless Hand Cleaner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59555-302-03Industrial Strength Waterless Hand Cleaner50 mL in 1 BOTTLE, PUMPLOTION502
59555-302-04Industrial Strength Waterless Hand Cleaner59 mL in 1 BOTTLE, DISPENSINGLOTION592
59555-302-08Industrial Strength Waterless Hand Cleaner236 mL in 1 BOTTLE, DISPENSINGLOTION2362
59555-302-09Industrial Strength Waterless Hand Cleaner473 mL in 1 BOTTLE, PUMPLOTION4732
59555-302-10Industrial Strength Waterless Hand Cleaner946 mL in 1 BOTTLE, PUMPLOTION9462
59555-302-11Industrial Strength Waterless Hand Cleaner3785 mL in 1 BOTTLE, PUMPLOTION37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59555-302INDUSTRIAL STRENGTH WATERLESS HAND CLEANER (BENZALKONIUM CHLORIDE) LOTION [R & R LOTION, INC]2Legacy NDC, 6 package rows20210128_9d0d67bd-b0c4-4620-8719-93544201fa9b.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59555-30259555-302-03, 59555-302-04, 59555-302-09, 59555-302-08, 59555-302-10, 59555-302-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzalkonium ChlorideF5UM2KM3W7ACTIB
water059QF0KO0RIACT
Xanthan GumTTV12P4NEEIACT
Calcium GluconateSQE6VB453KIACT
Sodium BenzoateOJ245FE5EUIACT
GluconolactoneWQ29KQ9POTIACT
Behentrimonium Methosulfate5SHP745C61IACT
Cetostearyl Alcohol2DMT128M1SIACT
Glyceryl 1-Stearate258491E1RZIACT
PEG-100 StearateYD01N1999RIACT
Cetyl Alcohol936JST6JCNIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
Shea ButterK49155WL9YIACT
.Alpha.-TocopherolH4N855PNZ1IACT
GlycerinPDC6A3C0OXIACT
Potassium Hydrolyzed JOJOBA EstersCH428W5O62IACT
cholecalciferol1C6V77QF41IACT
vitamin A81G40H8B0TIACT
PumiceNT5NN5KL16IACT

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
ab80a6eb-1f36-459a-8bc2-b3edba4967d59d0d67bd-b0c4-4620-8719-93544201fa9b2021-01-15WarningsExact identifier
spl id: ab80a6eb-1f36-459a-8bc2-b3edba4967d5
spl set id: 9d0d67bd-b0c4-4620-8719-93544201fa9b

Reported adverse events (FAERS/openFDA)#

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