Main information

  • Trade name:
  • UltraClean OmegaFactors
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug



  • Available in:
  • UltraClean OmegaFactors
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217882
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


UltraClean OmegaFactors

ARTG entry for

Medicine Listed


FIT-BioCeuticals Limited

Postal Address

PO Box 6454,ALEXANDRIA, NSW, 2015


ARTG Start Date


Product category




Approval area

Listed Medicines


Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in

the list of 'Colourings permitted in medicines for oral use'.

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


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.


1. UltraClean OmegaFactors

Product Type

Single Medicine Product

Effective date



If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist.

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

WARNING - When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.

The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents

for men.

Standard Indications

Specific Indications

[1] The DHA in fish oil is essential for the normal development and functioning of the retina and brain.

[2] Omega-3 fatty acids play an important role in growth and development.

[3] Omega-3 fatty acids are essential for normal healthy brain development.

[4] Omega -3 fatty aids are essential for healthy eye function.

[5] Source of Omega 3 fatty acids for maintenance of good health.

[6] Vitamin A may help support normal healthy functioning of the immune system.

[7] Vitamin D intake is required for healthy bone development and maintenance.

[8] Vitamin D plays an important role in the development, growth and mineralization/maintenance of a healthy skeleton.

[9] Vitamin D is required for healthy cell development, differentiation and maturation.

[10] Adequate vitamin D is important for the maintenance and support of a normal healthy immune system.

[11] Vitamin D is required for the normal healthy growth of children's bones.

[12] Adequate iodine intake is essential for normal brain development.

[13] Iodine is required for the production of thyroid hormones, which are necessary for normal brain development and cognition.

PI5 Helps in the development and maintenance of bones and teeth especially in childhood.

PI16 Helps normal growth and development.

PI166 Helps support cognitive health.

PI190 Helps support brain function.

Additional Product information

Pack Size/Poison information

Public Summary

Page 1 of

Produced at 26.11.2017 at 05:50:25 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

Pack Size

Poison Schedule


1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration


Visual Identification

Active Ingredients


5 microgram

concentrated fish Omega-3 triglycerides

526 mg

potassium iodide

40 microgram

retinol palmitate

112.2 microgram

© 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 05:50:25 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