FDA.reportPublic FDA data

Shieldplex

Manufacturer
CLT Logistics, Inc
Effective date
2022-02-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:10

Label at a glance#

ProductShieldplex
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

Lather in hands with water for at least 30 seconds. Rinse well.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic skin cleanser

Use

INDICATIONS & USAGE SECTION

  • Antiseptic (skin) cleanser
  • Medicated (skin) cleanser
  • Antibacterial (skin) cleanser
  • Eliminates harmful bacteria/germs
  • Effective in destroying (harmful) bacteria to provide antiseptic cleansing
  • For personal hand hygiene to help prevent the spread of bacteria

Warnings

WARNINGS SECTION

For external use only.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Lather in hands with water for at least 30 seconds. Rinse well.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua/Eau/Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glycol Distearate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Matricaria recutita (Chamomile) Extract, Parfum, Methylchloroisothiazolinone (and) Methylisothiazolinone, Citric Acid.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1

Label 2Label 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN3
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD3
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY3
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75490-006-012022-07-29C16284748780-1d6a99b39-b679-a426-e053-dadaa90af4c2d6d7c68f-a94b-4a66-935d-e092a4171ae3
75490-006-022022-07-29C16284748780-1d6a99b39-b679-a426-e053-dadaa90af4c2d6d7c68f-a94b-4a66-935d-e092a4171ae3
75490-006-012022-02-09C16284748780-1d6a99b39-b679-a426-e053-dadaa90af4c2d6d7c68f-a94b-4a66-935d-e092a4171ae3
75490-006-022022-02-09C16284748780-1d6a99b39-b679-a426-e053-dadaa90af4c2d6d7c68f-a94b-4a66-935d-e092a4171ae3
75490-006-012022-01-28C16284748780-1d6a99b39-b679-a426-e053-dadaa90af4c2d6d7c68f-a94b-4a66-935d-e092a4171ae3
75490-006-022022-01-28C16284748780-1d6a99b39-b679-a426-e053-dadaa90af4c2d6d7c68f-a94b-4a66-935d-e092a4171ae3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75490-006-01Shieldplex473 mL in 1 BOTTLE, PUMPSOAP4733
75490-006-02Shieldplex946 mL in 1 BOTTLE, PUMPSOAP9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75490-006SHIELDPLEX (BENZALKONIUM CHLORIDE) SOAP [CLT LOGISTICS, INC]3Legacy NDC, 2 package rows20220210_d6d7c68f-a94b-4a66-935d-e092a4171ae3.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75490-00675490-006-01, 75490-006-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCOL DISTEARATE13W7MDN21WIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHAMOMILEFGL3685T2XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
d79a8f54-f6a5-62a7-e053-2995a90a098cd6d7c68f-a94b-4a66-935d-e092a4171ae32022-02-09WarningsExact identifier
spl id: d79a8f54-f6a5-62a7-e053-2995a90a098c
spl set id: d6d7c68f-a94b-4a66-935d-e092a4171ae3

Reported adverse events (FAERS/openFDA)#

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