FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Goodwin Co.
Effective date
2021-01-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:36:29

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

For hand washing to decrease bacteria on the skin Recommended for repeated use

Dosage and administration

▪ Pump a small amount of foam into palm of hand ▪ Rub thoroughly over all surfaces of both hands for 15 seconds ▪ Rinse with potable water

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Directions

DOSAGE & ADMINISTRATION SECTION

▪ Pump a small amount of foam into palm of hand

▪ Rub thoroughly over all surfaces of both hands for 15 seconds

▪ Rinse with potable water

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 right away.

Warnings

WARNINGS SECTION

For external use only

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Uses

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin

Recommended for repeated use

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide, citric acid

Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hand sanitizerhand sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098199benzalkonium chloride 0.13 % Topical GelPSN6
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCD6
1098199benzalkonium chloride 0.13 % Topical GelSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64972-100-012023-01-30C16284748780-1f386c649-fe90-0266-e053-dadaa90a7c1aHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64972-100-01Hand Sanitizer236 mL in 1 BOTTLEGEL2366

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64972-100HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [GOODWIN CO.]6Legacy NDC, 1 package rows20210107_a129b99c-d34d-0144-e053-2a95a90ab329.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64972-10064972-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCO GLUCOSIDEICS790225BIACT
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT

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
b8402924-b5e8-0acd-e053-2a95a90a1805a129b99c-d34d-0144-e053-2a95a90ab3292021-01-06WarningsExact identifier
spl id: b8402924-b5e8-0acd-e053-2a95a90a1805
spl set id: a129b99c-d34d-0144-e053-2a95a90ab329

Reported adverse events (FAERS/openFDA)#

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