Medsafe: New Zealand Medicines and Medical Devices Safety Authority

MEDSAFE


New Zealand Medicines and Medical
Devices Safety Authority

Revised: 26 August 2026

Medicines

 

Medsafe Product Detail

File ref: TT50-10190
Trade Name Dose Form Strength Identifier
Microshield PVP Povidone-Iodine Surgical Handwash Topical solution 75 mg/mL
Sponsor Application date Regulatory status Classification
Schulke New Zealand Limited
P O Box 95
Auckland 1010
10/07/2017 Consent given
Approval date:19/07/2018
General sale

Composition

Component Ingredient Manufacturer
topical solutionActive 
 Povidone-iodine 7.5%{relative} (+16% overage, equivalent to iodine 0.75% w/v )ISP Technologies Inc
Highway 95
Calvert City KY 42029
UNITED STATES OF AMERICA
 Excipient 
 Ammonium nonoxynol-4-sulfate
 Citric acid monohydrate
 Dibasic sodium phosphate
 Glycerol
 Hyetellose
 Fragrance ESS9090
 Lauryl pyrrolidone
 Potassium iodide
 Purified water
 Sodium laureth sulfate

Production

Manufacturing step Manufacturer
Finished Product TestingEnsign Laboratories Pty Limited
490-500 Wellington Road
Mulgrave
VIC 3170
AUSTRALIA
Manufacture of Active IngredientISP Technologies Inc
Highway 95
Calvert City KY 42029
UNITED STATES OF AMERICA
Manufacture of Final Dose FormEnsign Laboratories Pty Limited
490-500 Wellington Road
Mulgrave
VIC 3170
AUSTRALIA
PackingEnsign Laboratories Pty Limited
490-500 Wellington Road
Mulgrave
VIC 3170
AUSTRALIA
Secondary PackagingPharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022
NZ Site of Product ReleaseSchulke New Zealand Limited
Level 14, PwC Tower
188 Quay Street
Auckland 1010

Packaging

Package Contents Shelf life
Bag, plastic, LLDPE/LDPE1.5 L18 months from date of manufacture stored at or below 25°C
Bottle, plastic, HDPE500 mL24 months from date of manufacture stored at or below 25°C

Indications

Broad spectrum antimicrobial surgical handwash indicated for antimicrobial handwashing, for surgical handwashing and for preoperative body washing or showering

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
10/07/2017New Lower-risk Medicine ApplicationNew lower-risk medicineGranted25/07/2017
31/08/2018Changed Medicine NotificationFinished product packing site - Grade 1; Administrative fee (CMN)Granted10/09/2018