WONG TO YICK WOOD LOCK MEDICATED BALM (FORMULA VII)

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

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Active ingredient:
Achyranthes bidentata,Angelica polymorpha,Angelica pubescens,Boswellia carterii,Carthamus tinctorius,Clematis chinensis,Corydalis turtschaninovii,Curcuma zedoaria,Dipsacus asper,Drynaria fortunei,Eucommia ulmoides,Gentiana macrophylla,Myrrh,Saposhnikovia divaricata,Sparganium stoloniferum,turpentine oil,wintergreen oil,Zanthoxylum nitidum
Available from:
Shen Neng Herbal Medicines Group Pty Ltd
Authorization status:
Listed
Authorization number:
320936

Public Summary

Summary for ARTG Entry:

320936

WONG TO YICK WOOD LOCK MEDICATED BALM (FORMULA VII)

ARTG entry for

Medicine Listed

Sponsor

Shen Neng Herbal Medicines Group Pty Ltd

Postal Address

1 Clarke Street,GUILDFORD, NSW, 2161

Australia

ARTG Start Date

29/07/2019

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

Sponsors must confirm the absence of aristolochic acids, or herbal species known to contain these acids, in all medicines containing herbal material

derived from any of the following plant genera - Akebia, Asarum, Bragantia, Clematis, Cocculus, Diploclisia, Menispernum, Saussurea, Sinomenium,

Stephania, Vladimiria.

The confirmation must be undertaken by chemical analysis using Liquid Chromatography Mass Spectrometry (LC-MS). The methodology used should

adhere to best practice according to contemporary scientific literature.

Confirmatory evidence is to be provided to the Director of Listing Compliance, Complementary and OTC Medicines Branch, prior to supply of each batch

in Australia. The evidence submitted to the TGA is to include the certificate of analysis, all relevant details of the methodology, such as analytical method

validation data, and the raw results.

All supporting evidence must be approved by the TGA prior to supply of the batch in Australia.

This medicine contains a preparation of Carthamus tinctorius flower for oral use. From 1 July 2011 all Listed Medicines containing preparations of

Carthamus tinctorius flower for oral use must include the label advisory statement 'Do not use if pregnant or likely to become pregnant'.

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.

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.

Products

1. WONG TO YICK WOOD LOCK MEDICATED BALM (FORMULA VII)

Product Type

Single Medicine Product

Effective date

23/08/2019

Permitted Indications

Traditionally used in Chinese medicine to decrease/reduce/relieve mild joint aches and pains

Traditionally used in Chinese medicine to decrease/reduce/relieve muscle cramps

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

Traditionally used in Chinese medicine to helps decrease/reduce/relieve symptoms of muscle sprain/strain

Traditionally used in Chinese medicine to decrease/reduce/relieve muscle pain/ache/soreness

Traditionally used in Chinese medicine to decrease/reduce/relieve bruise pain

Indication Requirements

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

Product presentation must only refer to mild joint symptoms.

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

osteoporosis.

Product presentation must not imply or refer to serious musculoskeletal or neurological conditions.

Standard Indications

Public Summary

Page 1 of

Produced at 29.08.2019 at 06:06:37 AEST

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

No Standard Indications included on Record

Specific Indications

Warnings

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

Contains methyl salicylate

Do not use if pregnant or likely to become pregnant (or words to that effect)

Avoid contact with eyes (or words to that effect).

If irritation develops, discontinue use. (Not less than 1.5 mm in height)

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

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Liniment

Route of Administration

Topical

Visual Identification

Active Ingredients

Achyranthes bidentata

1.3 mg/mL

Equivalent: Achyranthes bidentata (Dry)

1.3 mg/mL

Angelica polymorpha

1 mg/mL

Equivalent: Angelica polymorpha (Dry)

1 mg/mL

Angelica pubescens

1.6 mg/mL

Equivalent: Angelica pubescens (Dry)

1.6 mg/mL

Boswellia carterii

1 mg/mL

Equivalent: Boswellia carterii (Dry)

1 mg/mL

Carthamus tinctorius

1 mg/mL

Equivalent: Carthamus tinctorius (Dry)

1 mg/mL

Clematis chinensis

1 mg/mL

Equivalent: Clematis chinensis (Dry)

1 mg/mL

Corydalis turtschaninovii

1 mg/mL

Equivalent: Corydalis turtschaninovii (Dry)

1 mg/mL

Curcuma zedoaria

1 mg/mL

Equivalent: Curcuma zedoaria (Dry)

1 mg/mL

Dipsacus asper

1.6 mg/mL

Equivalent: Dipsacus asper (Dry)

1.6 mg/mL

Drynaria fortunei

1.3 mg/mL

Equivalent: Drynaria fortunei (Dry)

1.3 mg/mL

Eucommia ulmoides

1.3 mg/mL

Equivalent: Eucommia ulmoides (Dry)

1.3 mg/mL

Gentiana macrophylla

1 mg/mL

Equivalent: Gentiana macrophylla (Dry)

1 mg/mL

Myrrh

1 mg/mL

Saposhnikovia divaricata

1.6 mg/mL

Equivalent: Saposhnikovia divaricata (Dry)

1.6 mg/mL

Sparganium stoloniferum

1 mg/mL

Equivalent: Sparganium stoloniferum (Dry)

1 mg/mL

turpentine oil

190 mg/mL

Public Summary

Page 2 of

Produced at 29.08.2019 at 06:06:37 AEST

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

wintergreen oil

229 mg/mL

Zanthoxylum nitidum

1.6 mg/mL

Equivalent: Zanthoxylum nitidum (Dry)

1.6 mg/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 3 of

Produced at 29.08.2019 at 06:06:37 AEST

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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