XYLOCAINE

Main information

  • Trade name:
  • XYLOCAINE 5% OINTMENT lidocaine (lignocaine) 50mg/g tube (Reformulation)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XYLOCAINE 5% OINTMENT lidocaine (lignocaine) 50mg/g tube (Reformulation)
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215796
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215796

XYLOCAINE 5% OINTMENT lidocaine (lignocaine) 50mg/g tube (Refomulation)

ARTG entry for

Medicine Registered

Sponsor

Aspen Pharmacare Australia Pty Ltd

Postal Address

34-36 Chandos Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

9/10/2013

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. XYLOCAINE 5% OINTMENT lidocaine (lignocaine) 50mg/g tube (Reformulation)

Product Type

Single Medicine Product

Effective date

9/10/2013

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Temporary relief of pain associated with minor burns, non-blistered sunburn, insect bites, sore nipples.,Anaesthesia of mucous membranes e.g. various

anal conditions such as haemorrhoids and fissures.,Anaesthetic lubricant during examination and instrumentation e.g. proctoscopy,

sigmoidoscopy.,Surface anaesthesia of the gums prior to injection, before deep scaling and in conjunction with the fitting of new dentures.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Tube

48 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

35 grams

(S2) Pharmacy Medicine

10 grams

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Ointment

Route of Administration

Rectal

Oral Application

Topical

Visual Identification

White to greyish white ointment

Active Ingredients

lidocaine (lignocaine)

50 mg/g

© 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 23.11.2017 at 08:32:25 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

19-9-2018

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