Bell's Wintergreen Ointment

Land: Malta

Taal: Engels

Bron: Medicines Authority

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Bijsluiter Bijsluiter (PIL)
16-05-2024
Productkenmerken Productkenmerken (SPC)
16-05-2024

Werkstoffen:

CAJUPUT OIL, EUCALYPTUS OIL, METHYL SALICYLATE, MENTHOL

Beschikbaar vanaf:

Bell Sons & Co. (Druggists) Limited Gifford House, Slaidburn Crescent, Southport, Mersyside PR 9 9AL, United Kingdom

ATC-code:

M02AC

INN (Algemene Internationale Benaming):

CAJUPUT OIL 0.12 % (W/V) EUCALYPTUS OIL 1 % (W/V) METHYL SALICYLATE 9 % (W/V) MENTHOL 0.5 % (W/V)

farmaceutische vorm:

OINTMENT

Samenstelling:

CAJUPUT OIL 0.12 % (W/V) EUCALYPTUS OIL 1 % (W/V) METHYL SALICYLATE 9 % (W/V) MENTHOL 0.5 % (W/V)

Prescription-type:

OTC

Therapeutisch gebied:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Autorisatie-status:

Withdrawn

Autorisatie datum:

2006-05-31

Productkenmerken

                                 
Page 1 of 4 
 
SUMMARY OF PRODUCT CHARACTERISTICS 
 
 
PRODUCT SUMMARY 
 
1. 
NAME OF THE MEDICINAL PRODUCT 
 
 
Bell’s Wintergreen Ointment 
 
 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
 
Sweet Birch Oil BPC    
 
0.12% v/w* 
 
Cajuput Oil BPC  
 
 
0.12% v/w* 
 Eucalyptus 
Oil 
   1% 
v/w* 
 Menthol 
BP 
   0.5% 
w/w** 
 Methyl 
Salicylate 
BP 
  9% 
v/w* 
 
 
  * additional 15% overage 
 
** additional 20%  
 
 
3. PHARMACEUTICAL 
FORM 
 
 Ointment 
 
 
4. CLINICAL 
PARTICULARS 
 
4.1 THERAPEUTIC 
INDICATIONS 
 
 
For the relief of pain in arthritis, rheumatism, lumbago, sciatica
and other muscular and 
  
rheumatic conditions by application to the skin. 
 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
 
 
Massage gently into the affected area two or three times daily.
 
 
Not to be used for children under 5.  
 
4.3 CONTRAINDICATIONS 
 
 Hypersensitivity 
to 
any 
of the ingredients.  
 
4.4 
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 
 
 
Keep out of reach of children. 
 
For external use only.  
 
None specified when used externally. 
 Store 
below 
30
o
C. 
 
Keep away from eyes and mucous membranes.        
 
If symptoms persist consult your doctor. 
 
Discontinue use if excessive irritation occurs.  
 
Page 2 of 4 
 
4.5 
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION 
 
 None 
known 
 
4.6 PREGNANCY 
AND 
LACTATION 
 
 
No reported effects. 
 
4.7 
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 
 
 None 
 
4.8 UNDESIRABLE 
EFFECTS 
 
 
None specified when used externally.  Skin irritation may rarely
occur. 
 
4.9 OVERDOSE 
 
 Not 
applicable 
 
 
5. PHARMACOLOGICAL 
PROPERTIES 
 
5.1 
PHARMACODYNAMIC PROPERTIES 
 
 
Methyl Salicylate has the action of salicylates, i.e. analgesic and
anti-inflammatory.  
 
 
Sweet birch oil contains Methyl Salicyla
                                
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