Indication of topical pain relief gel consisting DICLOFENAC, METHYL SALICYLATE, LINSEED OIL AND MENTHOL AS KEY INGREDIENTS

1. In rheumatic conditions like Arthritis and Spondylitis conditions
the patient has to undergo a prolonged therapy of anti-
inflammatory drugs. Since oral medications over a long-term
use are known to cause potential systemic side effects, a
topical anti-inflammatory agent is always preferred. Studies
conducted in both animals and humans indicate that topical
application of Gel combination allows the penetration of active
ingredients through the skin into deeper layers such as the
subdermal, fascia, musculature, joint capsule and synovial fluid.
In tissues where vascularization is rather poor, such as tendons,
it is an advantage that the active substance can directly reach
the target, as opposed to systemic administration.
Combination gel consist of following ingredients:-
Diclofenac Diethylamine, Methyl Salicylate, Virgin Linseed Oil
and Menthol

2. Moreover, topical application of Diclofenac achieves high
therapeutic concentrations in the target areas without being
immediately taken into systemic circulation. This leads to a very
low concentration in plasma and to reduced possibility of
systemic side effects. This is particularly important in elderly, as
they normally suffer from rheumatological disorders and are
highly prone to adverse drug reactions, drug interactions and
compliance problems.
Methyl Salicylate acts as a counter irritant and gives relief when
used for painful muscles and joints. Menthol acts as a cooling
and soothing agent, and also offers analgesic effect when
applied to the skin. Virgin Linseed Oil is an emollient and has
the advantage of lubricating and moisturizing the skin.

3. INDICATIONS:
1.Traumatic inflammation of the tendons, ligaments, muscles
and joints due to sprains, strains and bruises.
2. Localized form of soft tissue rheumatism.
3. Osteoarthritis.
METHOD OF APPLICATION :
Combination gel should be gently applied to the affected site 3
to 4 times daily.
Treatment should be reviewed after 14 days or after 28 days, if
used for osteoarthritis. After application, hands should be
washed, unless they are the sites being treated

4. CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients of Acetylsalicylic acid
or any other Non-Steroidal Anti-inflammatory Drugs.
PRECAUTIONS:
Should be applied only to intact, non-diseased skin, and not to
skin wound or open injuries. It should not be used with
occlusion; it should not be allowed to come into contact with
the eyes or mucous membranes and should never be taken by
mouth.

5. SIDE EFFECTS:
Local - COMBINATION GEL is usually well tolerated. Local
irritation, erythema, pruritis or dermatitis may occasionally
occur. Skin photosensitivity, desquamation, atrophy,
discoloration and vesicular eruptions have been reported in
isolated cases.
General Systemic absorption of Combination gel is low,
compared with plasma levels obtained following oral
administration of Diclofenac. However, where COMBINATION
GEL is applied to a relatively large area of skin and over a
prolonged period, the possibility of systemic side effects cannot
be excluded.
DIRECTIONS FOR BREAKING THE SEAL OF THE TUBE:
COMBINATION GEL tube is protectively sealed at the nozzle of
the tube. Before use, break the seal by piercing it with the help
of the pointed projection provided inside the cap.