Deep Relief Topical Cream

DEEP RELIEF CREAM

 

DOSAGE FORM AND STRENGTH

Topical Cream

Strength: Menthol 5.91% w/w

Eucalyptus Oil 1.97% w/w

Methyl Salicylate 12.80% w/w

Turpentine Oil 1.47% w/w

 

HISTORY OF ACTIVE INGREDIENTS

Methyl Salicylate is a salicylic acid derivative and provides local irritant effect. Menthol when applied to the skin dilates the blood vessels, causing a sensation of coldness followed by an analgesic effect. It has also applied to the forehead, presumably as a counter irritant, for relief of headache. Eucalyptus oil has anti-inflammatory and analgesic effect when applied topically. Turpentine oil has rubefacient property.

 

NET CONTENT

Composition:

Strength: Menthol 5.91% w/w

Eucalyptus Oil 1.97% w/w

Methyl Salicylate 12.80% w/w

Turpentine Oil 1.47% w/w

Cream base q.s.

 

CLINICAL PHARMACOLOGY

ATC CODE:

Methyl Salicylate M02A, N02BA

 

PHARMACODYNAMICS

Menthol relieves itching, dilates the vessels causing a sensation of coldness followed by an analgesic effect. Methyl salicylate has the actions of the salicylates. It is readily absorbed through the skin and has counter-irritant properties. Eucalyptus oil has anti-inflammatory and analgesic effect when applied topically. Turpentine oil has rubefacient property.

 

PHARMACOKINETICS

The product exerts its action locally; little or no absorption is expected to occur.

 

INDICATION AND USAGE

Aches and pains of joints and muscles associated with arthritis, backaches, fibrositis, lumbago and sciatica.

 

CONTRAINDICATION

Not to be used on children under 6 years old.

Do not apply to skin abrasions.

Do not apply to irritated skin.

Hypersensitivity to the active substances or to any of the excipients.

Contraindicated where there is known hypersensitivity to aspirin, other salicylates, or other nonsteroidal anti-inflammatory drugs (including when taken by mouth) especially where associated with a history of asthma.

If irritation develops, use of the product should be discontinued.

 

INTERACTIONS

There have been reports that topical salicylates may potentiate the anticoagulant effects of warfarin. Menthol has also been reported to interact with warfarin (when taken orally), decreasing its effectiveness.

 

WARNINGS

Long-term continuous topical therapy should be avoided. Prolonged use may lead to skin sensitisation and the emergence of resistant organisms. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result.

 

PREGNANCY AND LACTATION

Pregnancy

Topical application may cause abnormalities of foetal development.

Lactation

Caution should be exercised when using topically.

Keep all medicines out of the reach of children.

 

PRECAUTIONS

Not on broken skin. Avoid contact with the eyes and sensitive areas of the skin. Wash hands thoroughly after use. If symptoms persist consult your doctor. Not to be use on children under 5 years. Discontinue use if excessive irritation occurs.

 

ADVERSE REACTION

Use sparingly on tender skin and do not cover immediately after application. If an adverse reaction occurs discontinue use immediately. Known side effects of menthol – contact dermatitis or eczema, hypersensitivity reactions characterised by urticaria, flushing and headache.

 

DRUG ABUSE AND DEPENDENCE

Not Applicable.

 

SYMPTOMS OF OVERDOSE AND ANTIDOTE

When used externally as directed, overdose is unlikely. However, symptoms of systemic salicylate poisoning have been reported after the application of salicylates to large areas of skin or for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested.

Antidote

Activated charcoal may be administered if significant quantities have been ingested within an hour of presentation. The plasma sailcylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuretics should not be used since it does not enhance sailcylate excretion and may cause pulmonary oedema. Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700mg/L. (5.1mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under ten years or over 70 years have increased risk of salicylate toxicity and may require dialysis at an earlier stage.

 

DOSAGE AND ADMINISTRATION

Gently massage Laborate Deep Relief Cream into the affected area until the penetration of the cream is complete. Apply 2-3 times daily.

 

THE PREPARATION FOR USE

Not Applicable.

 

PRESENTATION

30gm tube packed in a unit carton along with Patient Information leaflet.

 

STORAGE CONDITION

Store in a cool and dry place.

Protect from light.

Do not freeze.

 

ANY OTHER INFORMATION

For External use only.

 

NAFDAC Reg. No. 04-7274

 

MANUFACTURED IN INDIA BY

LABORATE PHARMACEUTICAL (INDIA)

E-11, IND. AREA, PANIPANT – 132 103

 

SOLE AGENT

EMBASSY PHARMACEUTICAL AND CHEMICALS LTD.

Lagos, Nigeria.

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