FDA.reportPublic FDA data

MedShield Products

Manufacturer
HWL Holdings, LLC | MEDIPROMTECH, LLC
Effective date
2022-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:44:28

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: 75446-123-02

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75446-123-012022-12-14C16284748780-1e4f33bdf-a1fb-d8a0-e053-dadaa90a6e4eHWL- Distributor Liquid
75446-123-022022-12-14C16284748780-1e4f33bdf-a1fb-d8a0-e053-dadaa90a6e4eHWL- Distributor Liquid
75446-123-012022-07-29C16284748780-1e4f33bdf-a1fb-d8a0-e053-dadaa90a6e4eHWL- Distributor Liquid
75446-123-022022-07-29C16284748780-1e4f33bdf-a1fb-d8a0-e053-dadaa90a6e4eHWL- Distributor Liquid

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
75446-12375446-123-01, 75446-123-02

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

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
efd5031f-5d87-c259-e053-2a95a90aedc1af5f7288-49d7-0c7f-e053-2995a90a829d2022-12-14WarningsExact identifier
spl id: efd5031f-5d87-c259-e053-2a95a90aedc1
spl set id: af5f7288-49d7-0c7f-e053-2995a90a829d

Reported adverse events (FAERS/openFDA)#

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