Vicks Vaporub

1. Name Of The Medicinal Product

Vicks Vaporub

2. Qualitative And Quantitative Composition

Name of the active substances:	Quantity	Unit	Reference standards
LEVOMENTHOL	2.75	% W/W	Eur. Ph
CAMPHOR	5.00	% W/W	Eur. Ph
EUCALYPTUS OIL	1.50	% W/W	Eur. Ph
TURPENTINE OIL	5.00	% W/W	FP

3. Pharmaceutical Form

An ointment which is rubbed on chest or added to hot water and the aromatics are inhaled.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of nasal catarrh and congestion, sore throat, also cough due to colds.

4.2 Posology And Method Of Administration

Adults:

Rub Vaporub liberally on the chest, throat and back. Rub in well over the whole area and leave nightclothes loose for easy inhalation.

or

Melt two teaspoons of Vaporub in very hot water and inhale the vapours.

Children (infants and babies over 2 years):

Apply lightly to chest and back. Rub gently and leave clothes loose for easy inhalation.

4.3 Contraindications

Vicks Vaporub is contraindicated in children under 2 years.

4.4 Special Warnings And Precautions For Use

In case of fever consult your doctor.

Do not swallow or place in nostrils.

As with all medicines keep out of the reach of children.

If symptoms persist consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None.

4.6 Pregnancy And Lactation

Although there is no evidence of any risk when Vaporub is used in pregnancy, such use is not recommended without medical advice.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None.

4.9 Overdose

Over dosage may result in skin irritation.

Misuse:

Swallowing of the ointment might cause gastrointestinal symptoms like vomiting and diarrhoea. Treatment is symptomatic.

Acute poisoning was observed after significant accidental consumption, with nausea, vomiting, abdominal pain, and headache, vertigo, feeling hot / flushing, convulsions, respiratory depression and coma.

Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Menthol, camphor, turpentine oil and eucalyptus oil act locally in the respiratory tract.

5.2 Pharmacokinetic Properties

The product exerts its action locally; little or no absorption is expected to occur.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Thymol

Cedarwood oil

White soft paraffin

6.2 Incompatibilities

None.

6.3 Shelf Life

40 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

VapoRub ointment is packed into 40g, 50g, 90g and 100g opaque, blue, polypropylene jars, closed with a green polypropylene thread screw cap and containing a 2mm thick PET/LDPE/EPE/LDPE/PET cap liner.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Procter & Gamble (Health & Beauty Care) Limited

The Heights

Brooklands

Weybridge

Surrey

KT13 0XP

8. Marketing Authorisation Number(S)

PL 0129/0130

9. Date Of First Authorisation/Renewal Of The Authorisation

15^th March 1999

10. Date Of Revision Of The Text

18/03/2011