FDA.reportPublic FDA data

Foaming 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 Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

Dosage & Administration Section

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

Inactive Ingredient Section

Inactive Ingredients Water, Aloe Barbadensis Leaf Juice, Disodium EDTA, Glycerin, Polyquaternium-11, Isopropyl Myristate, Tocopheryl Acetate, PEG-10 Dimethicone

Indication & Usage Section

INDICATIONS & USAGE SECTION

Uses Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

OTC-Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, contact a physician or poison control center.

Purpose Section

OTC - PURPOSE SECTION

Purpose Antibacterial Agent

OTC - Active Ingredient Section

Active Ingredient Ethyl Alcohol 62% v/v

Warnings Section

Warnings

For external use only.

Avoid contact with eyes. If eye contact occurs, flush with water.

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71303-688-312022-01-31C16284748780-1d6a99b39-ba7b-a426-e053-dadaa90af4c2RJ Schinner F688F
71303-688-412022-01-31C16284748780-1d6a99b39-ba7b-a426-e053-dadaa90af4c2RJ Schinner F688F
71303-688-312022-01-28C16284748780-1d6a99b39-ba7b-a426-e053-dadaa90af4c2RJ Schinner F688F
71303-688-412022-01-28C16284748780-1d6a99b39-ba7b-a426-e053-dadaa90af4c2RJ Schinner F688F

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
71303-68871303-688-31, 71303-688-41

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
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
POLYQUATERNIUM-11 (1000000 MW)0B44BS5IJSIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT

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
03a904f5-0641-f1e2-e063-6294a90af80e9cbea39d-4e07-90a8-e053-2a95a90a580c2023-08-24WarningsExact identifier
spl id: 03a904f5-0641-f1e2-e063-6294a90af80e
spl set id: 9cbea39d-4e07-90a8-e053-2a95a90a580c

Reported adverse events (FAERS/openFDA)#

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