Vicks Vaporub

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CAMPHOR, EUCALYPTUS OIL, TURPENTINE OIL, LEVOMENTHOL

Available from:

Procter & Gamble (Health & Beauty Care) Limited

ATC code:

R05X

INN (International Name):

CAMPHOR, EUCALYPTUS OIL, TURPENTINE OIL, LEVOMENTHOL

Pharmaceutical form:

OINTMENT

Composition:

CAMPHOR 5 percent weight/weight ; EUCALYPTUS OIL 1.5 percent weight/weight ; TURPENTINE OIL 5 percent weight/weight ; LEVOMENTHOL 2.75 percent weight/weight

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Authorised

Authorization date:

2007-03-02

Patient Information leaflet

VAPORUB
50g
98923127
_Ointment. PL 00129/0130, PA 441/2/2 Do not store above 25°C_
Expiry Date:
Lot no:
_INHALATION METHOD - DIRECTIONS (ADULTS ONLY):_
_Melt two teaspoons of Vicks VapoRub in a bowl of very hot (not
boiling) water._
_Inhale the medicated vapours for 10-15 minutes. Caution: Never reheat
the_
_mixture. Vicks and VapoRub are registered trademarks._
_Product licence holder; Procter & Gamble (Health & Beauty Care)
Limited,_
_The Heights, Brooklands, Weybridge, Surrey, KT13 0XP, UK_
_WARNINGS: Do not swallow or place in nostrils. If symptoms persist,_
_or in case of fever, consult your doctor or pharmacist. As with all
medicines,_
_keep out of reach and sight of children. For external use only. Do
not use on _
_children under 2 years of age._
_RUB ON METHOD - DIRECTIONS:_
_ADULTS: Rub liberally onto chest, throat and_
_back. Leave nightclothes loose to allow_
_vapours to be inhaled easily. CHILDREN OVER _
_2 YEARS: Apply lightly to chest_
_and back. Leave clothes loose for easy_
_inhalation. Rub in gently. ACTIVE INGREDIENTS:_
_Levomenthol 2.75% w/w, camphor 5.00%_
_w/w, eucalyptus oil 1.50% w/w, turpentine_
_oil 5.00% w/w. Also includes thymol, _
_cedarwood oil, white soft paraffin._
Print Free
Area for back print only 
(graduation of colour)
p
y
p
Bleed
PROFILE KEYS:
Laetus Code
Critical Tolerance
Area
Laetus Code
No. 647
g
g
7
31
92
98
P
_/_
_/_
_,_
_/_
_O_
_I_
Read Direction
LAETUS CODE:
No. 647
64007895.003
152mm
22
mm
30
mm
1
.5mm
1
.5
mm
6.5mm
R2
R2
R2
6
7
m
m
22mm
7mm
29mm
6
112222221
22
2
1
pg0452
1
pg0007
2
6
pg0473
3
7
pg0931
4
8
COLOURS: 4
TECHNICAL
DRAWING
mm
1 0
2 0
3 0
4 0
5 0
6 0
7 0
8 0
9 0
100
110
120
130
140
150
160
170
180
190
200
210
220
230
1
0
VERSION
REVISION
ASSET ID  8255
UIC  U5wLmL
PROJECT: Toledo UK 2008 
P- 050392
POA: 002
EAN: 
SIZE/BWR:  
PHARMA:

LAETUS CODE: 647
CODES
DATA MATRIX CODE:
JOB NO: 124530  FILE NO: 52200  
FILE NAME: 124530v1_14.ai
DATE: 10/02/2010  TIME: 09:30  OPERATOR: 27
SPEC: Pago002
IPMS: 9892312

Summary of Product characteristics

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
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
Eur. Ph
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
Hypersensitivity to any of the ingredients.
Do not administer to children < 2 years.
Do not use as an inhalation for children < 12 years.
Page 2 of 4
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The following patient groups should use with caution or consult a
doctor before use;
History of airway disease or pronounced hypersensitivity of the
airways / asthma
Keep out of reach and sight of children.
If symptoms persist, consult your doctor
TOPICAL:
Do not apply to broken skin, wounds or mucous membranes.
Do not swallow or apply directly onto the nostrils, eyes, mouth or
face.
For external use only
Do not bandage tightly. Do not use with heat wrap or any kind of heat.
INHALATION:
Do not use boiling water to prepare inhalations.
Do not heat or re-heat the mixture in a microwave.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known
4.6
PREGNANCY AND LACTATION
As with all medicines in pregnancy, care should be taken and as a
precaution this product
should not be used without medical advice durin