IE: Hayfever Roll-on

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

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Active ingredient:
Citrus limon,Cupressus sempervirens,Lavandula angustifolia,Matricaria chamomilla,Mentha X piperita
Available from:
Heritage Brands Ltd
Authorization status:
Listed
Authorization number:
351805

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Public Summary

Summary for ARTG Entry:

351805

IE: Hayfever Roll-on

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: Hayfever Roll-on

Product Type

Single Medicine Product

Effective Date

16/12/2020

Permitted Indications

Traditionally used in Aromatherapy to helps enhance/promote general health and wellbeing

Traditionally used in Aromatherapy to decrease/reduce/relieve symptoms of indigestion/dyspepsia

Traditionally used in Aromatherapy to decrease/reduce/relieve symptoms of stomach upsets

Traditionally used in Aromatherapy to decrease/reduce/relieve nausea

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

Linked indication - Decongestant/relieve nasal congestion

Linked indication - Decrease/reduce excess mucous

Linked indication - Decrease/reduce/relieve mild upper respiratory tract congestion

Traditionally used in Aromatherapy to decrease/reduce/relieve symptoms of allergic rhinitis

Linked indication - Decongestant/relieve nasal congestion

Linked indication - Decrease/reduce excess mucous

Linked indication - Decrease/reduce/relieve mild upper respiratory tract congestion

Traditionally used in Aromatherapy to helps decrease/reduce/relieve symptoms of seasonal allergies

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

Traditionally used in Aromatherapy to decrease/reduce/relieve nervous tension/unrest

Traditionally used in Aromatherapy to decrease/reduce/relieve symptoms of mild anxiety

Traditionally used in Aromatherapy to decrease/reduce/relieve headache symptoms

Traditionally used in Aromatherapy to decrease/reduce/relieve mild migraine symptoms

Traditionally used in Aromatherapy to decongestant/relieve nasal congestion

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

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

Traditionally used in Aromatherapy to decrease/reduce/relieve symptoms of mild eczema/dermatitis

Linked indication - Decrease/reduce/relieve itchy/prickling skin associated with mild eczema/dermatitis

Traditionally used in Aromatherapy to antimicrobial for minor cuts and abrasions

Indication Requirements

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

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

Product presentation must only refer to mild eczema.

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

Product presentation must only refer to mild anxiety.

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

Public Summary

Page 1 of

Produced at 11.01.2021 at 08:18:06 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

Product presentation must not imply or refer to gastro oesophageal reflux disease.

Respiratory tract infections must be qualified by 'mild'.

Product presentation must not imply or refer to serious allergic conditions such as anaphylaxis.

Product presentation must only refer to mild migraine.

Product presentation must not imply or refer to serious infections.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

This product contains material derived from nuts (or words to that effect).

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

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

Not to be taken.

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

If irritation develops, discontinue use.

If you have sensitive skin, test this product on a small area of skin before applying it to a large area.

Avoid contact with eyes (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

37.66 microlitre/mL

Cupressus sempervirens branch terminal leafy Oil essential

.7 microlitre/mL

Lavandula angustifolia herb top flowering Oil essential

3.5 microlitre/mL

Matricaria chamomilla flower Oil essential

.14 microlitre/mL

Mentha X piperita leaf Oil essential

28 microlitre/mL

Other Ingredients (Excipients)

Almond oil

Grape seed oil

mixed (low-alpha type) tocopherols concentrate

Soya Oil

© 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 08:18:06 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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