FDA.reportPublic FDA data

Premium Protection Antibacterial Hand

Manufacturer
Maintex | Morgan Gallacher Inc DBA Custom Chemical Formulators Inc
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:42:37

Label at a glance#

ProductPremium Protection Antibacterial Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

For hand washing to decrease bacteria on the skin.

Dosage and administration

Apply to wet hands. Work into a latther and rinse thoroughly. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride......0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

When Using this Product

GENERAL PRECAUTIONS SECTION

Avoid contact with the eyes.

In case of eye contact, rinse eyes thoroughly with water.

Do not ingest.

Stop use and contact a doctor if irritation and redness develop

and conditions persist.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help

or contact Posion Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to wet hands. Work into a latther and rinse thoroughly. Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cocamidopropyl Betaine, PEG 150 Distearate, Caprylyl Glucoside, Glycerine, Cocamide MIPA, Tetrasodium EDTA, Fragrance, Citric Acid, Aloe Vera, Benzisothiazol, Methylisothiozol, Yellow #5, Red #40

Premium Protection Antibacterial Hand Soap

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130765294116881GTIN-13: 0765294116881
EAN-13: 0765294116881
GTIN-12: 765294116881
UPC-A: 765294116881
GTIN storage (14 digits): 00765294116881		Premium Protection Antibacterial Hand Soap New Label-GALLON_REV20DEC23.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77617-002-01Premium Protection Antibacterial Hand3.80564 kg in 1 BOTTLE, PLASTICLIQUID3.805648
77617-002-02Premium Protection Antibacterial Hand4 in 1 BOXLIQUID48

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77617-00277617-002-01, 77617-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA FLOWER575DY8C1ERIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
MAGNESIUM NITRATE77CBG3UN78IACT
MALTODEXTRIN7CVR7L4A2DIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
FD&C RED NO. 40WZB9127XOAIACT
EDETATE SODIUMMP1J8420LUIACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-12-12full-release2026-06-01 00:43:12

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
Premium Protection Antibacterial HandBENZALKONIUM CHLORIDEMaintex53bd6860-dde3-4525-ba1b-50f69be09abc2025-11-06WarningsExact identifier
ndc (package): 77617-002-02
ndc (package): 77617-002-01
ndc (product): 77617-002
ndc11 (package): 77617000201
ndc11 (package): 77617000202
spl id: b5076cff-1836-4873-b552-ec38eea80c45
spl set id: 53bd6860-dde3-4525-ba1b-50f69be09abc

Reported adverse events (FAERS/openFDA)#

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