Ralgex Freeze spray

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isopentane; Methoxymethane; Hydroxyethyl salicylate

Available from:

G.R. Lane Health Products Ltd

ATC code:

n/a

INN (International Name):

Isopentane; Methoxymethane; Hydroxyethyl salicylate

Dosage:

677.7mg/1gram ; 144.1mg/1gram ; 100mg/1gram

Pharmaceutical form:

Spray

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 10030200; GTIN: 5012509978655

Patient Information leaflet

Common Technical Document
Ralgex Freeze Spray
Module 1 – Administrative and Prescribing Information
Module 1.3 – Product Information
January 2015 - LB
Text to appear on the Patient Information Leaflet
RALGEX FREEZE SPRAY
Glycol Monosalicylate 10% w/w, Methoxymethane 14.41% w/w and
Isopentane 67.77% w/w
PATIENT INFORMATION LEAFLET
Pl ease read this leaflet carefully before using Ralgex Freeze Spray.
• Keep this leaflet, you may wish to read it again.
• Ask your pharmacist if you need more information or advice.
What is this spray used for?
This cutaneous spray solution is used for the symptomatic relief of
muscular pain and stiffness,
including backache, sciatica, lumbago, fibrositis, rheumatic pain.
It is also used for the symptomatic relief of sprains, strains and
bruises associated with sports
injuries, and stiffness following sporting exercise.
Before using this spray
Do not use…
• If you are allergic to any of the ingredients in this product, in
particular salicylates (e.g. aspirin) or
other non
‐
steroidal anti inflammatory drugs (including pain killers). See
‘What this spray contains'
for the full list of ingredients.
• On broken or inflamed skin.
• If you suffer from poor blood circulation which makes the toes and
fingers numb and pale
(Raynaud's disease).
Take special care…
• Some people experience stronger effects with Ralgex Freeze Spray
than others. Try on a small
area first.
• Not for use with occlusive dressings.
• Do not spray on the head or neck.
• Avoid inhalation and contact with the eyes.
• Always spray sparingly; over application can cause discomfort.
• Do not spray on sensitive body areas or broken skin or on large
areas of body.
• This spray is for external use only.
• Use with caution during pregnancy.
How to use this spray
Adults, the elderly and children 5 years and over:
• Shake well before use. in with the arrow pointing to the site of
pain
• Hold the can about 6 inches from the skin.
• Press button to spray 2
‐
3 short bursts.
• This may b

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ralgex Freeze Spray
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycol monosalicylate
10.0% w/w
Methoxymethane
14.41% w/w
Isopentane
67.77%w/w
3
PHARMACEUTICAL FORM
Topical spray
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic relief of muscular pain and stiffness, including backache,
sciatica, lumbago, fibrositis and rheumatic pain.
Symptomatic relief of sprains, strains and bruises associated with
sports injuries, and
stiffness following sporting exercise.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of Administration: External application to the skin
Adults, the elderly and children 5 years and over
Hold the container about 6 inches from the skin with the arrow
pointing to the site of
pain. Press the button to spray in 2-3 short bursts. This may be
repeated up to 4
times daily.
Not to be used on children under 5 years of age.
4.3
CONTRAINDICATIONS
Hypersensitivity to salicylates, Saliclic acid (or other non-steroidal
anti-
inflammatory drugs) or to any of the excipients listed in section 6.1.
Injuries involving broken or inflamed skin.
Raynaud’s disease.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product contains glycol salicylate and so should be used with
caution in
patients at increased risk of developing salicylate adverse effects.
The following appear on the product labelling:
Some people experience stronger effects with Ralgex than others. Try
on a
small area first.
Not for use with occlusive dressings.
Caution: Do not spray on head or neck.
Avoid inhalation and contact with the eyes.
Always spray sparingly: over application can cause discomfort.
Do not spray on sensitive body areas or broken skin or on large areas
of the
body.
If symptoms persist, consult your doctor.
For external use only.
Keep out of the sight and reach of children.
Caution: extremely flammable. Pressurised container. Protect from
sunlight and do
not expose to temperatures exceeding 50°C. Do not pierce or burn,
even after use.
Keep away from