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WOODWARDS BABY CHEST RUB

Active substance(s): EUCALYPTUS OIL / MENTHOL / TURPENTINE OIL

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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
Eucalyptus Oil BP
Menthol BP

3

5.0 %v/w
2.0 % v/w
2.0 % w/w

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 25ÂșC

6.5

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

6.6

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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