FDA.reportPublic FDA data

Kay Chemical Hand Sanitizer Foam

Manufacturer
Kay Chemical
Effective date
2024-07-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:59:42

Label at a glance#

ProductKay Chemical Hand Sanitizer Foam
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

For handwashing to decrease bacteria on the skin

Dosage and administration

Spread thoroughly onto hands and rub until dry

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 54.7 w/w (equivalent to 62.5% v/v)

Purpose

OTC - PURPOSE SECTION

Antiseptic 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.
  • Contents under pressure. Do not store at temperatures above 120°F (48°C), puncture or incinerate
  • Operate only with spout pointing down

Do not use

OTC - DO NOT USE SECTION

  • In eyes

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation or redness develop 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

  • Spread thoroughly onto hands and rub until dry

Other Information

OTHER SAFETY INFORMATION

  • for additional information, see Safety Data Sheet (SDS)
  • Medical Emergency: (877) 231-2615 or call collect 0 (952) 853-1713

INACTIVE INGREDIENT SECTION

Inactive Ingredients water (aqua), isobutane, glycerin, cetearyl alcohol, hydrofluorocarbon 152A, propane, polysorbate-60, sodium lauroyl lactylate, steareth-20, sodium benzoate, tert-butyl alcohol, denatonium benzoate

OTC - QUESTIONS SECTION

Questions? Call 1-800-529-5458

Representative Label and Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KAY®

Hand Sanitizer Foam

Net Contents: 425 g (15 oz)

Active Ingredient: 54.7% w/w (equivalent to 62.5% v/v)

1110978

ECOLAB

This product may be patented | Este producto

puede ser patentado: www.ecolab.com/patents

Distributed by | Distribuido por:

Kay Chemical Company · 8300 Capital Drive

Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

©2022 Kay Chemical Company

All rights reserved | Todas los derechos reservados

Made in USA | Hecho en Estados Unidos

822113 • KUSA 775938/8001/1122

Representative LabelRepresentative Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63146-309-132024-01-30C16284748780-11030e365-5248-111a-e063-dadaa90a10e2Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63146-309KAY CHEMICAL HAND SANITIZER FOAM (ETHYL ALCOHOL) SOLUTION [KAY CHEMICAL]4Legacy NDC20240704_981405a0-ba34-4aa0-b0a8-d74cd2427dd1.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63146-30963146-309-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
Water059QF0KO0RIACT
isobutaneBXR49TP611IACT
GLYCERINPDC6A3C0OXIACT
1,1-DIFLUOROETHANE0B1U8K2ME0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPANET75W9911L6IACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
STEARETH-20L0Q8IK9E08IACT
SODIUM BENZOATEOJ245FE5EUIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT

Source Document#

Source XML · Source PDF

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
864c17d3-0e75-4b78-8b93-d479ebae29c4981405a0-ba34-4aa0-b0a8-d74cd2427dd12025-12-31WarningsExact identifier
spl set id: 981405a0-ba34-4aa0-b0a8-d74cd2427dd1

Reported adverse events (FAERS/openFDA)#

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