RALGEX Cutaneous Spray Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GLYCOL MONOSALICYLATE ETHYL SALICYLATE METHYL SALICYLATE METHYL NICOTINATE

Available from:

Seton Products Ltd

Pharmaceutical form:

Cutaneous Spray Solution

Authorization date:

1997-05-14

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ralgex Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycol monosalicylate
4.80 % w/v
Ethyl salicylate
4.80 % w/v
Methyl salicylate
0.96 % w/v
Methyl nicotinate
1.60 % w/v
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Cutaneous spray, solution
A pungent spray.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the topical relief of symptoms of musculoskeletal pain such as in lumbago, sciatica, muscle strains.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical
Recommended Dosage Schedules
Adults, the elderly and children 12 years and over
Shake well before use.
Repeat applications at intervals of less than two hours are not recommended.
Hold the container about 6 inches from the skin with the arrow pointing to the site of pain and depress the button to
spray in 2-3 short bursts. This may be repeated up to 4 times daily. The spray is rapidly absorbed by the skin and
massage is not required.
If, after use, an increased effect is required, cover the sprayed area with a pad of cotton wool held in place by adhesive
tape.
Not to be used on children under 12 years of age.
4.3 CONTRAINDICATIONS
Salicylate hypersensitivity, or hypersensitivity to any constituents of the spray. Injuries involving broken skin.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 01/03/2010_
_CRN 2078998_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contact with the eyes and mucous membranes should be avoided.
Hands should be thoroughly washed after contact with product during application.
If you are receiving medication, contact your doctor before using.
If symptoms persist, consult your doctor.
For ex