IE: Balance Roll-on

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

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Active ingredient:
Citrus sinensis,Cupressus sempervirens,Jasminum officinale,Lavandula angustifolia,pelargonium graveolens,Rosa x damascena
Available from:
Heritage Brands Ltd
Authorization status:
Listed
Authorization number:
351802

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Public Summary

Summary for ARTG Entry:

351802

IE: Balance 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: Balance Roll-on

Product Type

Single Medicine Product

Effective Date

16/12/2020

Permitted Indications

Traditionally used in Aromatherapy to maintain/support energy levels

Traditionally used in Aromatherapy to relieve weariness/tiredness/fatigue/feeling of weakness

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

Traditionally used in Aromatherapy to maintain/support blood circulation/flow to the peripheral areas of the body (legs, hands and feet)

Traditionally used in Aromatherapy to decrease/reduce/relieve muscle cramps

Traditionally used in Aromatherapy to helps decrease/reduce/relieve mild muscle spasms/twitches

Traditionally used in Aromatherapy to relieve irritability

Traditionally used in Aromatherapy to calms the mind

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 support healthy emotional/mood balance

Traditionally used in Aromatherapy to decrease/reduce/relieve sleeplessness

Traditionally used in Aromatherapy to decrease/reduce/relieve menstrual spasms/cramps

Traditionally used in Aromatherapy to decrease/reduce/relieve menstruation pain/dysmenorrhoea

Traditionally used in Aromatherapy to decrease/reduce/relieve symptoms of premenstrual tension

Linked indication - Decrease/reduce feelings of aggression/irritability associated with premenstrual tension

Linked indication - Decrease/reduce/relieve mood changes/mood swings associated with premenstrual tension

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

Linked indication - Decrease/reduce/relieve hot flushes associated with menopause

Linked indication - Decrease/reduce/relieve moodiness/mood swings associated with menopause

Traditionally used in Aromatherapy to decrease/reduce/relieve skin dryness

Indication Requirements

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 musculoskeletal or neurological conditions.

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

Public Summary

Page 1 of

Produced at 11.01.2021 at 08:19:30 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 chronic fatigue syndrome.

Product presentation must not imply or refer to serious cardiovascular conditions.

Product presentation must only refer to mild migraine.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Not to be taken.

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

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

Keep out of reach of children (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 sinensis fruit peel Oil essential

57.89 microlitre/mL

Cupressus sempervirens branch terminal leafy Oil essential

1.4 microlitre/mL

Jasminum officinale flower Oil essential

.14 microlitre/mL

Lavandula angustifolia herb top flowering Oil essential

7 microlitre/mL

pelargonium graveolens leaf Oil essential

3.5 microlitre/mL

Rosa x damascena flower Oil essential

.07 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 08:19:30 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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