FDA.reportPublic FDA data

Foaming Instant Hand Sanitizer

Manufacturer
RJ Schinner | Kutol Products, Inc.
Effective date
2023-08-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:26:54

Label at a glance#

ProductFoaming Instant Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Intended for repeated use.

Dosage and administration

Directions: Apply a small amount to palm. Briskly rub, covering hands with product until dry.

Label contents#

Full prescribing information#

Dosage and Administration Section

DOSAGE & ADMINISTRATION SECTION

Directions: Apply a small amount to palm. Briskly rub, covering hands with product until dry.

Inactive Ingredient Section

Inactive Ingredients: Water, Propylene Glycol, Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice, Tocopheral Acetate, Peg-& Glyceral Cocoate, Fragrance, Phenoxyethanol, Tetrasodium EDTA

Indications and Usage Section

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Intended for repeated use.

Keep Out Of Reach Of Children Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of Reach Of Children: If swallowed, contact a physician or poison control center.

OTC Purpose Section

OTC - PURPOSE SECTION

Purpose: Antibacterial Agent

OTC Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Benzalkonium Chloride 0.13% w/w

Warnings Section

Warnings: For External Use Only

Contact with Eyes: If contact occurs, flush with water

Stop Use if, in rare instances, redness or irritation develop. If condition persists more than 72 hours, contact a physician.

Primary Display Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Display LabelPrimary Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71303-207-312022-01-31C16284748780-1d6a99b39-51ce-a426-e053-dadaa90af4c2RJ Schinner F207
71303-207-412022-01-31C16284748780-1d6a99b39-51ce-a426-e053-dadaa90af4c2RJ Schinner F207
71303-207-312022-01-28C16284748780-1d6a99b39-51ce-a426-e053-dadaa90af4c2RJ Schinner F207
71303-207-412022-01-28C16284748780-1d6a99b39-51ce-a426-e053-dadaa90af4c2RJ Schinner F207

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71303-20771303-207-41, 71303-207-31

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPYLENE GLYCOL 1,2-DISTEARATET65PN3O37HIACT
EDETATE SODIUMMP1J8420LUIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
ALOE VERA LEAFZY81Z83H0XIACT

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
03a8d6f3-00f8-5ae3-e063-6294a90a91c29c9666bf-8428-03fa-e053-2a95a90abb482023-08-24WarningsExact identifier
spl id: 03a8d6f3-00f8-5ae3-e063-6294a90a91c2
spl set id: 9c9666bf-8428-03fa-e053-2a95a90abb48

Reported adverse events (FAERS/openFDA)#

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