SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Baby Chest Rub Woodwards baby chest rub

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Turpentine Oil BP 5.0 %v/w Eucalyptus Oil BP 2.0 % v/w Menthol BP    2.0    % w/w

3 PHARMACEUTICAL FORM

Inhalant rub

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of nasal catarrh and congestion due to cold

4.2 Posology and method of administration

Adults, the Elderly, Children and Babies over Three months

Rub on the chest, throat and back morning and night.

Leave bedding and clothes loose to allow easy inhalation of the vapour. Not to be given to children under three months.

4.3 Contraindications

Known hypersensitivity to the active ingredients.

4.4 Special warnings and precautions for use

For external use only. Do not apply directly to the nostrils. Keep the rub away from the eyes. Do not use on babies aged under three months.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Pregnancy and lactation

Not contraindicated.

4.7 Effects on ability to drive and use machines

None stated

4.8 Undesirable effects

Can cause hypersensitivity reactions, including contact dermatitis and skin blistering.

4.9 Overdose

(Ingestion of the contests of whole container) causes nausea, vomiting and diarrhoea, breathing difficulties leading to respiratory collapse. Application of a product containing menthol to the nostrils of infants can cause instant collapse. Stomach should be emptied by aspiration and lavage and a purgative given.

Any convulsions can be controlled by intravenous diazepam 5-10mg, or short acting barbiturates.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

An inhalant chest rub containing menthol and a mixture of volatile oils. The inhalation of vapours from these ingredients stimulates the membrane of the respiratory tract loosening the mucous and catarrh in the nasal Passages giving relief to congestion.

5.2 Pharmacokinetic properties

Not Applicable

5.3 Preclinical safety data

None Stated.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Oil of cedarwood Oil of nutmeg Oil of thyme White soft paraffin

6.2    Incompatibilities

None known

6.3    Shelf life

60 months unopened

6.4 Special precautions for storage

Store below 25°C

6.5 Nature and contents of container

White glass jars containing 28g of product with R3/38mm polycarb screw cap and packed into cartons

Special precautions for disposal

None stated

7    MARKETING AUTHORISATION HOLDER

Ayrton Saunders Limited, North Way,

Walworth Industrial Estate, Andover,

SP10 5AZ United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 16431/0071

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

27/02/2009

10    DATE OF REVISION OF THE TEXT

27/02/2009