ORION

Main information

  • Trade name:
  • ORION CALAMINE LOTION BP calamine 15% w/v lotion bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ORION CALAMINE LOTION BP calamine 15% w/v lotion bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 21235
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

21235

ORION CALAMINE LOTION BP calamine 15% w/v lotion 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

8/10/1991

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

Conditions

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

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

Products

1. ORION CALAMINE LOTION BP calamine 15% w/v lotion bottle

Product Type

Single Medicine Product

Effective date

3/07/2002

Warnings

No Warnings included on Record

Standard Indications

This product accepted for registration/listing as 'currently supplied' at the time of commencement of the Act. Indications held in ARTG paper records. (Old

code)

Specific Indications

For the relief of minor skin irritations, insect bites and sunburn.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

2 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

200mL

Not scheduled. Not considered by committee

100mL

Not scheduled. Not considered by committee

Components

1. Medicine Component

Dosage Form

Lotion

Route of Administration

Topical

Visual Identification

Pale pink suspension

Active Ingredients

calamine

150 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 02.12.2017 at 05:36:58 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

There are no safety alerts related to this product.

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