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Drugs and Health Products

Flower Essences

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredients.

Notes

  • By submitting a PLA referencing this monograph, the applicant is attesting that the product will comply fully with the recommended conditions of use outlined in this monograph. The conditions of use include methods of preparations, source materials, doses, durations of use, combinations of medicinal ingredients, and risk statements.
  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.
  • The use of the electronic Product License Application form (ePLA) is not possible for products associated with this monograph.

Date

June 24, 2013

Proper name(s), Common name(s), and Source material(s)

Table 1 Products may contain one or more of the following ingredients

Proper name(s) Common name(s) Source material(s)
Aesculus carnea Red Horse chestnut Twigs with flowering pyramids and young leaves.
Aesculus hippocastanum Horse chestnut Buds and twigs
Aesculus hippocastanum Horse chestnut Flowers
Agrimonia eupatoria Agrimony Flower
Aqua petra Rock water Well or spring water
Bromus ramosus Wild oat Flowering spikelets
Calluna vulgaris Heather Flowering sprays and leaves
Carpinus betulus Hornbeam Young twigs with leaves, and flowers
Castanea sativa Sweet chestnut Young twigs with leaves, and flowers
Centaurium umbellatum Centaury Flower
Ceratostigma willmottianum Cerato Flower
Cichorium intybus Chicory Flower
Clematis vitalba Clematis Flower
Fagus sylvatica Beech Flower
Gentianella amarella Gentian Flower
Helianthemum nummularium Rock rose Flower
Hottonia palustris Water violet Flower
Ilex aquifolium Holly Flowering twigs
Impatiens glandulifera Impatiens Flower
Juglans regia Walnut Young shoots, leaves and flowers
Larix decidua Larch Twigs with the young green leaf-tufts, and flowers
Lonicera caprifolium Honeysuckle Flowering clusters with stalk and leaves
Malus pumila Crab apple Leaves and flower clusters
Mimulus guttatus Mimulus Flower
Olea europaea Olive Flower clusters
Ornithogalum umbellatum Star of Bethlehem Flowering clusters
Pinus sylvestris Pine Young shoots with flowers
Populus tremula Aspen Catkins
Prunus cerasifera Cherry plum Flowering twigs
Quercus robur Oak Catkins
Rosa canina Wild rose/Dog rose Flowers and leaves
Salix vitellina Willow Catkins
Scleranthus annuus Scleranthus Flowering stems and leaves
Sinapis arvensis Mustard Flower-heads and seed pods
Ulex europaeus Gorse Flowers
Ulmus procera Elm Twigs with flower clusters
Verbena officinalis Vervain Flower
Vitis vinifera Vine Flowering clusters

Route(s) of administration

  • Oral
  • Topical

Dosage form(s)

  • The acceptable pharmaceutical oral dosage forms include, but are not limited to granules, liquids or lozenges.
  • The acceptable pharmaceutical topical dosage forms include, but are not limited to creams, ointments or liquids.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of

Flower Essence preparation/remedy/medicine

Dose

Statement(s) to the effect of

Subpopulation(s)

Adults (≥ 18 years)

Potency

The dilution for each medicinal ingredient must be equivalent to 5X.

Method of preparation

The method of preparation must be one of the following:

  • BHomP Method Br 9
  • BHomP Method Br 10

Directions for use

All products

Take as directed by a health care practitioner.

Specific products

Liquids:
2 drops in water and sip at intervals throughout the day or as directed by a health care practitioner.

Granules:
5 granules, twice per day, before lunch and evening meal or as directed by a health care practitioner.

Lozenges:
1 or 2 lozenges, twice per day or as directed by a health care practitioner.

Cream/ointment:
Clean affected area and then apply cream/ointment to area thoroughly. Cover with a bandage if necessary.

Duration of use

No statement required.

Risk information

Statement(s) to the effect of

Cautions and warnings

If symptoms persist or worsen, consult a health care practitioner.

If you are pregnant or breastfeeding, consult a health care practitioner prior to use.

Contraindications

No statement required.

Known adverse reactions

No statement required.

Non-medicinal ingredients

Must be chosen from the current NNHPD Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Specifications

References reviewed

  • Bach E. The Twelve Healers and Other Remedies. Saffron Walden (GB): The C.W. Daniel Company Ltd, 1999.
  • BHomP 1999: British Homoeopathic Pharmacopoeia. London (GB): British Association of Homoeopathic Manufacturers, 1999.
  • Justice Canada. Next link will take you to another Web siteFood and Drug Regulations (C.R.C., c. 870) [Internet]. Ottawa (ON): Justice Canada.[Current: 2013 May 20; Last amended: 2013 March 21; Accessed 2013 May 29].
  • Ramsell J. Questions and Answers: Explaining the Basic Principles and Standards of The Bach Flower Remedies. Saffron Walden (GB): The C.W. Daniel Company Ltd, 1996.
  • Scheffer M. Bach Flower Therapy: Theory and Practice. Rochester (VT): Healing Arts Press, 1998.
  • Weeks N, Bullen V. The Bach Flower Remedies: Illustrations and Preparations. Saffron Walden (GB): The C.W. Daniel Company Ltd, 1998.
  • Wheeler FJ. The Bach Remedies Repertory. Saffron Walden (GB): The C.W. Daniel Company Ltd, 1996.