FDA.reportPublic FDA data

Retail Hand Sanitizer

Manufacturer
Ecolab Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:29:13

Label at a glance#

ProductRetail Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

For handwashing to decrease bacteria on the skin

Dosage and administration

Apply liberal amount into hand Spread by rubbing hands together Rub to dryness with attention to are around nails and between fingers

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethanol 60% by volume

Purpose

OTC - PURPOSE SECTION

Antispetic handwash

Uses

INDICATIONS & USAGE SECTION

  • For handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

  • For external use only
  • FLAMMABLE, keep away from fire or flame, heat, sparks and sources of static discharge

Do not use

OTC - DO NOT USE SECTION

  • In eyes
  • On deep cuts or puncture wounds

When using this product

OTC - WHEN USING SECTION

  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and rendess develop

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • Eye or skin irritation or redenss occurs 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

  • Apply liberal amount into hand
  • Spread by rubbing hands together
  • Rub to dryness with attention to are around nails and between fingers

Other information

REFERENCES SECTION

  • For additional information, see Safety Data Sheet (SDS)
  • For emergency medical information in USA, call (877) 231-2615 or call collect 0 (952) 853-1713

INACTIVE INGREDIENT SECTION

Inactive ingredients water (aqua), isopropyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, myristyl alcohol

OTC - QUESTIONS SECTION

Questions? Call 1-800-529-5458

Principal display panel and representative label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RETAIL

Hand Sanitizer

Sanitizante de manos

KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY

MANTENGASE FUERA DEL ALCANCE DE LOS NIÑOS • SOLO PARA USO INSTITUCIONAL

Ethanol 60% by volume

60% de etanol por volume

Net contents: 40.6 US fl oz (1200 ml)

FRSUSA 777648/8000/0920

Meets the requirements for Hand Antiseptics as specified in section 2-301.16 of the 2017 Model Food Code.

Cumple con los requisitos estipulados de antisépticos para manos tal como se especifican en la sección 2-301.16 del Código Modelo para Alimentos

(2017 Model Food Code).

SDS-NC-872, SDS-NJ-20007

Distributed by / Distribuido por:

Kay Chemical Company

8300 Capital Drive · Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

©2020 Kay Chemical Company

All rights reserved | Todas los derechos reservados

Made in USA | Hecho en Estados Unidos

This product may be patented | Este producto puede ser patentado:

www.ecolab.com/patents

representative labelrepresentative label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039483ethanol 60 % Topical SolutionPSN1
1039483ethanol 0.6 ML/ML Topical SolutionSCD1
1039483ethanol 60 % Topical SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-684-56Retail Hand Sanitizer1200 mL in 1 BOTTLE, PLASTICLIQUID12001

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47593-68447593-684-56

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
TROLAMINE9O3K93S3TKIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MYRISTYL ALCOHOLV42034O9PUIACT

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
Retail Hand SanitizerALCOHOLEcolab Inc.55e65545-9869-413b-8239-bd2d43fe36d82025-12-30WarningsExact identifier
ndc (package): 47593-684-56
ndc (product): 47593-684
ndc11 (package): 47593068456
spl id: fc56d278-64e0-47c9-b4a3-18461ede62a3
spl set id: 55e65545-9869-413b-8239-bd2d43fe36d8

Reported adverse events (FAERS/openFDA)#

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