FDA.reportPublic FDA data

MedShield Products

Manufacturer
HWL Holdings, LLC
Effective date
2021-12-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:45:34

Label at a glance#

ProductMedShield Products
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

Rub thoroughly over all the surfaces of both hands. Rub hands together briskly until dry.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1% Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

to decrease bacteria on the skin that could cause disease

Warnings

WARNINGS SECTION

For external use only-hands

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

if skin irritation develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Rub thoroughly over all the surfaces of both hands.
  • Rub hands together briskly until dry.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerol, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL NDC: 75446-111-14100 mL NDC: 75446-111-14100 mL NDC: 75446-111-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038791benzalkonium chloride 0.1 % Topical SolutionPSN4
1038791benzalkonium chloride 1 MG/ML Topical SolutionSCD4
1038791benzalkonium chloride 0.1 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75446-111-022022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-042022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-062022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-082022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-102022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-122022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-142022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-162022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-182022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-202022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-222022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-242022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-262022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-282022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-302022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-322022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-342022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid
75446-111-362022-07-29C16284748780-1e4f33bdf-b04c-d8a0-e053-dadaa90a6e4eMedShield Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75446-111-02MedShield Products18 mL in 1 BOTTLE, PLASTICLIQUID184
75446-111-04MedShield Products30 mL in 1 BOTTLE, PLASTICLIQUID304
75446-111-06MedShield Products50 mL in 1 BOTTLE, PLASTICLIQUID504
75446-111-08MedShield Products60 mL in 1 BOTTLE, PLASTICLIQUID604
75446-111-10MedShield Products75 mL in 1 BOTTLE, PLASTICLIQUID754
75446-111-12MedShield Products80 mL in 1 BOTTLE, PLASTICLIQUID804
75446-111-14MedShield Products100 mL in 1 BOTTLE, PLASTICLIQUID1004
75446-111-16MedShield Products118 mL in 1 BOTTLE, PLASTICLIQUID1184
75446-111-18MedShield Products236 mL in 1 BOTTLE, PLASTICLIQUID2364
75446-111-20MedShield Products250 mL in 1 BOTTLE, PLASTICLIQUID2504
75446-111-22MedShield Products473 mL in 1 BOTTLE, PLASTICLIQUID4734
75446-111-24MedShield Products946 mL in 1 BOTTLE, PLASTICLIQUID9464
75446-111-26MedShield Products1000 mL in 1 BOTTLE, PLASTICLIQUID10004
75446-111-28MedShield Products1183 mL in 1 BOTTLE, PLASTICLIQUID11834
75446-111-30MedShield Products1892 mL in 1 BOTTLE, PLASTICLIQUID18924
75446-111-32MedShield Products3785 mL in 1 BOTTLE, PLASTICLIQUID37854
75446-111-34MedShield Products10000000 mL in 1 BOTTLE, PLASTICLIQUID100000004
75446-111-36MedShield Products12000000 mL in 1 BOTTLE, PLASTICLIQUID120000004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75446-111MEDSHIELD PRODUCTS (HAND SANITIZER) LIQUID [HWL HOLDINGS, LLC]4Legacy NDC, 18 package rows20211210_a421e839-1538-7ae2-e053-2a95a90a3666.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75446-11175446-111-04, 75446-111-06, 75446-111-08, 75446-111-10, 75446-111-12, 75446-111-14, 75446-111-16, 75446-111-18, 75446-111-20, 75446-111-22, 75446-111-24, 75446-111-26, 75446-111-28, 75446-111-30, 75446-111-32, 75446-111-34, 75446-111-36, 75446-111-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML · Source PDF

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
d2ba925b-cbf2-fecd-e053-2995a90ab3cda421e839-1538-7ae2-e053-2a95a90a36662021-12-09WarningsExact identifier
spl id: d2ba925b-cbf2-fecd-e053-2995a90ab3cd
spl set id: a421e839-1538-7ae2-e053-2a95a90a3666

Reported adverse events (FAERS/openFDA)#

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