Bosisto's

Main information

  • Trade name:
  • Bosisto's Natural Antiseptic Spray
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bosisto's Natural Antiseptic Spray
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218725
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218725

Bosisto's Natural Antiseptic Spray

ARTG entry for

Medicine Listed

Sponsor

Felton Grimwade & Bosisto's Pty Ltd

Postal Address

PO Box 74,OAKLEIGH SOUTH, VIC, 3167

Australia

ARTG Start Date

20/12/2013

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine,

(b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be

kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records

to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine

outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National

Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. Bosisto's Natural Antiseptic Spray

Product Type

Single Medicine Product

Effective date

20/12/2013

Warnings

If symptoms persist consult your healthcare practitioner (or words to that effect).

Contains ethanol. (or words to that effect).

Standard Indications

May assist in the management of minor wounds (cuts, scratches, abrasions)

Treatment of minor skin disorders such as wounds, scratches, eczema, dermatitis, bruising, cuts and abrasions. [Warning S required]

For the symptomatic relief of minor wounds (cuts, scratches, abrasions).

Specific Indications

Natural Antiseptic that kills 99.99% of germs and bacteria

For managment of pimples.

For minor insect bites and stings.

For management of tinea.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Spray

Route of Administration

Topical

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:31:06 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

Visual Identification

Active Ingredients

Eucalyptus Oil

136 mg/mL

lavender oil

9 mg/mL

Melaleuca Oil

18 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 2 of

Produced at 26.11.2017 at 04:31:06 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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