FDA.reportPublic FDA data

PRO-LINK OPTIMUM Foaming Medicated Handwash

Manufacturer
Pro-Link, Inc.
Effective date
2018-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:45:50

Label at a glance#

ProductPRO-LINK OPTIMUM Foaming Medicated Handwash
Active ingredientTRICLOSAN
Label structure7 sections

Dosage and administration

Wet hands Apply a small amount of product and work into a lather Rinse well and dry hands completely

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Triclosan 0.3%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • Handwash to help decrease bacteria on the skin before and after contact with a person under medical care or treatment
  • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts

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

  • Wet hands
  • Apply a small amount of product and work into a lather
  • Rinse well and dry hands completely

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Propylene Glycol, Alcohol, Lauric Acid, Ethanolamine, Disodium Cocoamphodiacetate, Lactic Acid, Isopropyl Alcohol, PEG-4, Polyquaternium-10, Sodium Metabisulfite, Sodium Sulfite, Tetrasodium EDTA, Sodium Sulfate, Fragrance (Parfum), Iodopropynyl Butylcarbamate, Green 3 (CI 42053)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct LabelProduct LabelProduct LabelProduct LabelProduct Label

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66908-09666908-096-42

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
TRICLOSAN4NM5039Y5XACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MIACT
LAURIC ACID1160N9NU9UIACT
MONOETHANOLAMINE5KV86114PTIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
LACTIC ACID33X04XA5ATIACT
ISOPROPYL ALCOHOLND2M416302IACT
POLYETHYLENE GLYCOL 200R95B8J264JIACT
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT
SODIUM METABISULFITE4VON5FNS3CIACT
SODIUM SULFITEVTK01UQK3GIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM SULFATE0YPR65R21JIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
FD&C GREEN NO. 33P3ONR6O1SIACT

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
57032ed5-1ef1-49d9-a84b-8cf4c77e83c5028a9e91-ac71-45df-9ddc-2e47fe410d832018-11-20WarningsExact identifier
spl id: 57032ed5-1ef1-49d9-a84b-8cf4c77e83c5
spl set id: 028a9e91-ac71-45df-9ddc-2e47fe410d83

Reported adverse events (FAERS/openFDA)#

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