QUELLADA

Main information

  • Trade name:
  • QUELLADA SCABIES TREATMENT LOTION permethrin 50mg/mL bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • QUELLADA SCABIES TREATMENT LOTION permethrin 50mg/mL bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 52603
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

52603

QUELLADA SCABIES TREATMENT LOTION permethrin 50mg/mL bottle

ARTG entry for

Medicine Registered

Sponsor

Orion Laboratories Pty Ltd T/A Perrigo Australia

Postal Address

25-29 Delawney Street,BALCATTA, WA, 6021

Australia

ARTG Start Date

16/06/1995

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. QUELLADA SCABIES TREATMENT LOTION permethrin 50mg/mL bottle

Product Type

Single Medicine Product

Effective date

3/11/2014

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the treatment of infestation with Sarcoptes scabiei (scabies)

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

50mL

Not scheduled. Not considered by committee

100mL

Not scheduled. Not considered by committee

Components

1.

Dosage Form

Lotion

Route of Administration

Topical

Visual Identification

White to off-white lotion

Active Ingredients

Permethrin

50 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 01.12.2017 at 10:55:19 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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