ie: Immune

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
Citrus limon,Eucalyptus globulus,Origanum majorana,Santalum spicatum
Available from:
Heritage Brands Ltd
Authorization status:
Listed
Authorization number:
351807

Read the complete document

Public Summary

Summary for ARTG Entry:

351807

ie: Immune

ARTG entry for

Medicine Listed

Sponsor

Heritage Brands Ltd

Postal Address

PO Box 1435, CLAYTON SOUTH, VIC, 3169

Australia

ARTG Start Date

16/12/2020

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.

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 . ie: Immune

Product Type

Single Medicine Product

Effective Date

16/12/2020

Permitted Indications

Traditionally used in Aromatherapy to aids/assists with recovery from illness/convalescence

Traditionally used in Aromatherapy to relieve feelings of general malaise/general debility

Traditionally used in Aromatherapy to restorative tonic

Traditionally used in Aromatherapy to antipyretic/febrifuge/relieve mild fever/reduce body temperature/body cooling

Traditionally used in Aromatherapy to decrease/reduce/relieve symptoms of hayfever

Traditionally used in Aromatherapy to maintain/support immune system health

Traditionally used in Aromatherapy to enhance/improve/promote immune defence/immunity

Traditionally used in Aromatherapy to maintain/support healthy immune system function

Traditionally used in Aromatherapy to maintain/support immune system to fight illness

Traditionally used in Aromatherapy to enhance/promote/increase refreshing sleep

Traditionally used in Aromatherapy to decrease/reduce/relieve sleeplessness

Traditionally used in Aromatherapy to decongestant/relieve nasal congestion

Traditionally used in Aromatherapy to unblock/clear nasal passages

Traditionally used in Aromatherapy to decrease/reduce/relieve mild bronchial irritation

Traditionally used in Aromatherapy to soothe/calm the chest

Traditionally used in Aromatherapy to decrease/reduce/relieve symptoms of common colds and flu

Traditionally used in Aromatherapy to decrease/reduce/relieve mild upper respiratory tract congestion

Traditionally used in Aromatherapy to decrease/reduce/relieve the severity of symptoms of mild upper respiratory tract infections

Traditionally used in Aromatherapy to decrease/reduce/relieve symptoms of sinusitis

Traditionally used in Aromatherapy to decrease/reduce/relieve the severity of common cold symptoms

Traditionally used in Aromatherapy to relieve symptoms of mild upper respiratory tract infections

Traditionally used in Aromatherapy to decrease/reduce/relieve symptoms of common cold

Traditionally used in Aromatherapy to decrease/reduce/relieve mild bronchial cough

Traditionally used in Aromatherapy to decrease/reduce/relieve cough

Traditionally used in Aromatherapy to relieve runny/dripping nose

Traditionally used in Aromatherapy to relieve symptoms of sore throat/pharyngitis

Indication Requirements

Label statement: Adults only, OR Not to be used in children under 2 years of age without medical advice (or words to that effect).

Public Summary

Page 1 of

Produced at 11.01.2021 at 08:17:04 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

Product presentation must not imply or refer to serious forms of respiratory disorders/diseases, such as: asthma, pneumonia, COAD, COPD, influenza.

Product presentation must only refer to mild bronchitis.

Label statement: Not to be used in children under 5 years.

Product presentation must not imply or refer to serious immunological diseases.

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to chronic fatigue syndrome.

Respiratory tract infections must be qualified by 'mild'.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

If symptoms persist, seek the advice of a healthcare professional.

Not to be taken.

Use in children under 12 years is not recommended.

Keep out of reach of children (or words to that effect).

Application to skin may increase sensitivity to sunlight (or words to that effect).

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Essential Oil

Route of Administration

Topical

Inhalation

Visual Identification

Active Ingredients

Citrus limon fruit peel Oil essential

599 microlitre/mL

Eucalyptus globulus branch terminal leafy Oil essential

300 microlitre/mL

Origanum majorana leaf Oil essential

100 microlitre/mL

Santalum spicatum stem heartwood Oil essential

1 microlitre/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 11.01.2021 at 08:17:04 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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