FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
State Industrial Products | Kutol Products Company
Effective date
2023-08-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:26:55

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
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.

INDICATIONS & USAGE SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Benzalkonium Chloride 0.13% v/v

WARNINGS SECTION

Warnings For external use only. Avoid contact with eyes. If 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water, Propylene Glycol, Fragrance, Tocopheryl Acetate, Tetrasodium EDTA, Cocamidoprpyl Betaine, PEG-7 Glyceryl Cocoate, Phenoxyethanol, Aloe Barbadensis Leaf Juice

OTC - PURPOSE SECTION

Purpose Antibacterial Agent

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

State Gentle FreshState Gentle Fresh

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64542-207-172022-01-31C16284748780-1d6a99b39-bbef-a426-e053-dadaa90af4c2State Industrial F207
64542-207-412022-01-31C16284748780-1d6a99b39-bbef-a426-e053-dadaa90af4c2State Industrial F207
64542-207-462022-01-31C16284748780-1d6a99b39-bbef-a426-e053-dadaa90af4c2State Industrial F207
64542-207-912022-01-31C16284748780-1d6a99b39-bbef-a426-e053-dadaa90af4c2State Industrial F207
64542-207-172022-01-28C16284748780-1d6a99b39-bbef-a426-e053-dadaa90af4c2State Industrial F207
64542-207-412022-01-28C16284748780-1d6a99b39-bbef-a426-e053-dadaa90af4c2State Industrial F207
64542-207-462022-01-28C16284748780-1d6a99b39-bbef-a426-e053-dadaa90af4c2State Industrial F207
64542-207-912022-01-28C16284748780-1d6a99b39-bbef-a426-e053-dadaa90af4c2State Industrial F207

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
64542-20764542-207-41, 64542-207-17, 64542-207-46, 64542-207-91

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
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
PROPYLENE GLYCOL 1-MYRISTATE5G38I12XFTIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT

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
03a8d6f3-00f7-5ae3-e063-6294a90a91c2a0358bc4-eeae-52a5-e053-2995a90ab54b2023-08-24WarningsExact identifier
spl id: 03a8d6f3-00f7-5ae3-e063-6294a90a91c2
spl set id: a0358bc4-eeae-52a5-e053-2995a90ab54b

Reported adverse events (FAERS/openFDA)#

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