Hormone Hero

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

Buy It Now

Active ingredient:
Arctium lappa,Asparagus racemosus,calcium hydrogen phosphate dihydrate,menaquinone 7,pyridoxal 5-phosphate monohydrate,Salvia officinalis,Schisandra chinensis,Vitex agnus-castus,Withania somnifera,zinc gluconate
Available from:
Mister Jones
Authorization status:
Listed
Authorization number:
350982

Read the complete document

Public Summary

Summary for ARTG Entry:

350982

Hormone Hero

ARTG entry for

Medicine Listed

Sponsor

Mister Jones

Postal Address

PO Box Southport BC, Southport, QLD, 4215

Australia

ARTG Start Date

7/12/2020

Product Category

Medicine

Status

Active

Approval Area

Listed Medicines

Conditions

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 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 . Hormone Hero

Product Type

Single Medicine Product

Effective Date

7/12/2020

Permitted Indications

Traditionally used in Western herbal medicine to alterative/blood cleanser/depurative/purifier

Traditionally used in Western herbal medicine to maintain/support natural liver cleansing/detoxification processes

Traditionally used in Ayurvedic medicine to balya/improve body strength

Traditionally used in Ayurvedic medicine to vrishya/aphrodisiac/Increase in virility

Traditionally used in Ayurvedic medicine to rasayan/rejuvenative tonic

Traditionally used in Western herbal medicine to maintain/support physical endurance/capacity/stamina

Traditionally used in Western herbal medicine to maintain/support vitality

Traditionally used in Ayurvedic medicine to maintain/support vitality

Traditionally used in Ayurvedic medicine to rejuvenating tonic

Traditionally used in Western herbal medicine to maintain/support general health and wellbeing

Maintain/support general health and wellbeing

Maintain/support hair health

Maintain/support nail health/strength/thickness

Aid/assist/helps connective tissue production/formation

Maintain/support bone health

Aids/assists healthy bone development/growth/building

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

Helps prevent dietary (state vitamin/mineral/nutrient) deficiency

Traditionally used in Ayurvedic medicine to adaptogen/Help body adapt to stress

Traditionally used in Western herbal medicine to adaptogen/Help body adapt to stress

Support healthy stress response in the body

Traditionally used in Ayurvedic medicine to relieve irritability

Traditionally used in Ayurvedic medicine to decrease/reduce/relieve nervous tension/unrest

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

Traditionally used in Western herbal medicine to maintain/support cognitive function/mental function

Support healthy emotional/mood balance

Traditionally used in Ayurvedic medicine to maintain/support female reproductive system health

Public Summary

Page 1 of

Produced at 11.01.2021 at 09:11:58 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

Traditionally used in Western herbal medicine to maintain/support/regulate healthy menstrual cycle

Traditionally used in Ayurvedic medicine to maintain/support/regulate healthy menstrual cycle

Decrease/reduce feelings of aggression/irritability associated with premenstrual tension

Decrease/reduce/relieve symptoms of premenstrual tension

Traditionally used in Western herbal medicine to decrease/reduce/relieve symptoms of premenstrual tension

Decrease/reduce/relieve symptoms of premenstrual tension

Traditionally used in Western herbal medicine to helps decrease/reduce/relieve night sweats associated with menopause

Traditionally used in Ayurvedic medicine to decrease/reduce/relieve symptoms of menopause

Traditionally used in Western herbal medicine to decrease/reduce/relieve symptoms of menopause

Decrease/reduce/relieve symptoms of menopause

Traditionally used in Western herbal medicine to decrease/reduce/relieve hot flushes associated with menopause

Decrease/reduce/relieve hot flushes associated with menopause

Traditionally used in Ayurvedic medicine to maintain/support healthy libido

Relieve symptoms of acne

Traditionally used in Western herbal medicine to relieve symptoms of acne

Traditionally used in Western herbal medicine to relieve minor skin eruptions

Decrease/reduce/relieve pimples

Traditionally used in Western herbal medicine to decrease/reduce/relieve symptoms of mild eczema/dermatitis

Maintain/support skin health

Indication Requirements

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

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

If Ayurvedic terminology is used on medicine label, label statement: Talk to a Ayurvedic practitioner/health professional if you are unsure if this medicine is

right for you.

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

Product presentation must only refer to detoxification in relation to natural body processes.

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

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

Note: this requirement is not intended to apply where the indications referring to osteoporosis specified in column 2 of Table 2 of this instrument are also

used.

Product presentation must only refer to mild eczema.

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

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not

replace a balanced diet.

Product presentation must only refer to mild anxiety.

Product presentation must not imply or refer to drugs/alcohol.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Vitex agnus-castus may affect hormones and medicines such as oral contraceptives. Consult your health professional before use' (or words to that effect).

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

Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Public Summary

Page 2 of

Produced at 11.01.2021 at 09:11:58 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

Arctium lappa root Extract dry concentrate

25 mg

Equivalent: Arctium lappa (Dry)

500 mg

Asparagus racemosus root Extract dry concentrate

43.75 mg

Equivalent: Asparagus racemosus (Dry)

875 mg

calcium hydrogen phosphate dihydrate

150.778 mg

Equivalent: calcium

35.11 mg

menaquinone 7

45 microgram

pyridoxal 5-phosphate monohydrate

7.05 mg

Equivalent: pyridoxine

4.5 mg

Salvia officinalis leaf Extract dry concentrate

150 mg

Equivalent: Salvia officinalis (Dry)

750 mg

Schisandra chinensis fruit Extract dry concentrate

15 mg

Equivalent: Schisandra chinensis (Dry)

375 mg

Vitex agnus-castus fruit Extract dry concentrate

50 mg

Equivalent: Vitex agnus-castus (Dry)

500 mg

Withania somnifera root Extract dry concentrate

37.5 mg

Equivalent: Withania somnifera (Dry)

750 mg

zinc gluconate

29.05 mg

Equivalent: zinc

3.75 mg

Other Ingredients (Excipients)

Carnauba Wax

colloidal anhydrous silica

croscarmellose sodium

crospovidone

hypromellose

macrogol 400

magnesium stearate

maltodextrin

microcrystalline cellulose

povidone

silicon dioxide

© 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 3 of

Produced at 11.01.2021 at 09:11:58 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

Similar products

Search alerts related to this product

Share this information