FDA.reportPublic FDA data

Instant Hand Sanitizer

Manufacturer
Fun Zone, Inc.
Effective date
2020-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:28:32

Label at a glance#

ProductInstant Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

Rub dime sized amount between hands until dry. For use by children under 6 years, adult supervision is required.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.095%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

To help reduce bacteria on hands.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes and lips.
  • If contact occurs, rinse with water.

Stop using this product and consult a doctor If

OTC - STOP USE SECTION

irritation or redness develops.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Rub dime sized amount between hands until dry.
  • For use by children under 6 years, adult supervision is required.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Polyquaternium-37, Glycerin, Propylene Glycol, Phenoxyethanol, PEG-40 Hydrogenated Castor Oil, Fragrance, Triethanolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle front labelimage of bottle front label

image of bottle back labelimage of bottle back label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2048259benzalkonium chloride 0.095 % Topical GelPSN1
2048259benzalkonium chloride 0.00095 MG/MG Topical GelSCD1
2048259benzalkonium chloride 0.095 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69583-035-012023-01-30C16284748780-1f386c649-c27f-0266-e053-dadaa90a7c1aInstant Hand Sanitizer 1.2oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69583-035-01Instant Hand Sanitizer35 mL in 1 BOTTLE, PLASTICGEL351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69583-035INSTANT HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [FUN ZONE, INC.]1Legacy NDC, 1 package rows20200906_ae9022c6-e30c-1933-e053-2a95a90a06f6.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69583-03569583-035-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
POLYQUATERNIUM-37 (10000 MPA.S)41QWS48DFNIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
ae905759-c6bf-cd0a-e053-2a95a90a32b0ae9022c6-e30c-1933-e053-2a95a90a06f62020-09-05WarningsExact identifier
spl id: ae905759-c6bf-cd0a-e053-2a95a90a32b0
spl set id: ae9022c6-e30c-1933-e053-2a95a90a06f6

Reported adverse events (FAERS/openFDA)#

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