FDA.reportPublic FDA data

Appeal Non-alcohol Foaming Hand Sanitizer

Manufacturer
SC Johnson Professional USA, Inc. | APEX International, Inc.
Effective date
2021-07-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:40:05

Label at a glance#

ProductAppeal Non-alcohol Foaming Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

to decrease bacteria on the skin that could cause disease recommended for repeated use

Dosage and administration

Wet hands thouroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride, 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • Avoid contact with broken skin.
  • Do not inhale or ingest.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • 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

  • Wet hands thouroughly with product and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Cocamidopropyl Betaine, Lauramine Oxide, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA

SPL UNCLASSIFIED SECTION

Distributed exclusively by:
Interline Brands
Jacksonville, FL 32207

PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11084-306-27

APP17103-04
102669

appeal

Non-alcohol
Foaming Hand Sanitizer
(dye and fragrance free)

1 Liter (33.8 fl oz)

Distributed exclusively by:
Interline Brands
Jacksonville, FL 32207
www.AppealProducts.com

Made by
SCJ PROFESSIONAL
A Family Company™

1000003257/1020

PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label
PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11084-30611084-306-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE SODIUMMP1J8420LUIACT

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
f851ea6d-5774-41af-9d75-015ac2622e1139bea7a9-ebae-4941-8385-ecec6e0a81e72023-12-11WarningsExact identifier
spl set id: 39bea7a9-ebae-4941-8385-ecec6e0a81e7

Reported adverse events (FAERS/openFDA)#

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