FDA.reportPublic FDA data

Instant Foam Non-alcohol PURE Hand Sanitizer

Manufacturer
SC Johnson Professional USA, Inc. | APEX International, Inc.
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:45:11

Label at a glance#

ProductInstant Foam Non-alcohol PURE Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

to decrease bacteria on the skin that could cause disease

Dosage and administration

Wet hands thouroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision.

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

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SCJ PROFESSIONAL
A Family Company™

NDC 11084-300-27

InstantFOAM™ Non-Alcohol PURE

HAND SANITIZER
Alcohol-Free FOAM Hand sanitizer - Dye & Perfume-Free

Stock #: 55857/4000007087

SC Johnson Professional USA, Inc.
Charlotte, NC 28217,
1-800-248-7190
www.scjp.com

1 L (33.8 fl oz)

deb
SKIN CARE

1000003036/0220

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label
PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN5
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD5
1020365benzalkonium chloride 0.13 % Topical FoamSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11084-300-01Instant Foam Non-alcohol PURE Hand Sanitizer47 mL in 1 BOTTLE, PLASTICLIQUID475
11084-300-12Instant Foam Non-alcohol PURE Hand Sanitizer1200 mL in 1 BOTTLE, PLASTICLIQUID12005
11084-300-27Instant Foam Non-alcohol PURE Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICLIQUID10005
11084-300-40Instant Foam Non-alcohol PURE Hand Sanitizer400 mL in 1 BOTTLE, PLASTICLIQUID4005
11084-300-66Instant Foam Non-alcohol PURE Hand Sanitizer1000 mL in 1 BOTTLELIQUID10005
11084-300-97Instant Foam Non-alcohol PURE Hand Sanitizer296 mL in 1 BOTTLE, PLASTICLIQUID2965

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11084-300INSTANT FOAM NON-ALCOHOL PURE HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [SC JOHNSON PROFESSIONAL USA, INC.]5Current NDC, Legacy NDC, 6 package rows20241220_fc557f8d-7ebe-4434-a350-602efbbb9c6e.zip

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
11084-30011084-300-27, 11084-300-12, 11084-300-97, 11084-300-01, 11084-300-40, 11084-300-66

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
Instant Foam Non-alcohol PURE Hand SanitizerBENZALKONIUM CHLORIDESC Johnson Professional USA, Inc.fc557f8d-7ebe-4434-a350-602efbbb9c6e2024-12-18WarningsExact identifier
ndc (package): 11084-300-40
ndc (package): 11084-300-27
ndc (package): 11084-300-01
ndc (package): 11084-300-97
ndc (package): 11084-300-12
ndc (package): 11084-300-66
ndc (product): 11084-300
ndc11 (package): 11084030001
ndc11 (package): 11084030066
ndc11 (package): 11084030040
ndc11 (package): 11084030027
ndc11 (package): 11084030012
ndc11 (package): 11084030097
spl id: 218bf8d3-a6db-4d18-8511-86adad611144
spl set id: fc557f8d-7ebe-4434-a350-602efbbb9c6e

Reported adverse events (FAERS/openFDA)#

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