DEEP FREEZE COLD GEL 2%W/W - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Deep Freeze Cold Gel 2%w/w

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Racemic menthol         2.0% w/w

3. PHARMACEUTICAL FORM

Gel for topical application to the skin

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

For the symptomatic relief of painful lesions of the muscles, tendons and joints.

4.2. Posology and method of administration

Adults (including the elderly)

Gently massage Deep Freeze Cold Gel into the affected area 3–4 times daily

Children (over five years)

Apply to the affected area 3–4 times daily

Children (under five years)

Not recommended

Directions for use

For topical application.

Apply over the affected area. Massage gently until completely absorbed into the skin.

4.3. Contraindications

Hypersensitivity to any of the components of the formulation.

4.4 Special warnings and precautions for use

■ Keep all medicines out of the sight and reach of children.

■ For external use only.

■ Hands should be washed immediately after use.

■ Avoid contact with eyes, mucous membranes and inflamed or broken skin.

■ Not for use with occlusive dressings.

■ May cause allergic reactions (possibly delayed).

■ Repeated application may give rise to hypersensitivity. Discontinue use if any rash appears.

■ If symptoms persist consult your doctor.

4.5. Interaction with other medicinal products and other forms of interaction

Not applicable.

4.6. Pregnancy and lactation

There is no known reason why this product should not be used during pregnancy or by breast-feeding mothers.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable Effects

Menthol may give rise to hypersensitivity reactions including contact dermatitis.

May cause allergic reactions (possibly delayed)

May cause application site burns (frequency cannot be estimated from the available data).

Although not recommended for children under 5 years nor for use on mucous membranes, use of the product on the nostrils of infants may result in apnoea and collapse.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

Yellow Card Scheme www.mhra.gov.uk/yellowcard

4.9. Overdose

Systemic side effects such as nausea, vomiting and ataxia are not thought to be a problem as significant absorption does not occur after topical application.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Menthol, when applied to the skin, dilates the blood vessels causing a sensation of coldness followed by an analgesic effect and subsequent deeper warmth as concentration increases.

5.2. Pharmacokinetic Properties

Menthol absorbed through the skin is transported to the liver. Some Phase I metabolism may occur in the skin but most occurs in the liver. The menthol is hydroxylated and then conjugated with glucuronide prior to circulation to the kidneys for excretion in the urine.

5.3. Preclinical Safety Data

The ingredient is subject to monographs in the British and European Pharmacopoeia and is documented in Martindale, The Extra Pharmacopoeia.

Therefore no pre-clinical data are included with this application.

6.

PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Isopropyl Alcohol

Carbomer

Triethanolamine (85%)

Methyl Hydroxybenzoate (E218)

Propyl Hydroxybenzoate (E216)

Patent Blue V E131

Purified Water

6.2. Incompatibilities

Not applicable to the intended use.

6.3. Shelf life

Three years.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Printed, collapsible aluminium tube with a high molecular weight epoxy resin lining. The tube is closed by a membrane nozzle and high density polyethylene cap which has a recessed piercer.

The tubes are filled to an average weight of 35, 50 or 100 g.

Not all pack sizes may be marketed.

6.6. Instructions for use and handling

None.

7.

MARKETING AUTHORISATION HOLDER

The Mentholatum Company Limited

1 Redwood Avenue

Peel Park Campus

East Kilbride

G74 5PE

8. MARKETING AUTHORISATION NUMBER(S)

PL 00189/0022

9. DATE OF FIRST AUTHORISATION/RE­NEWAL OF THE AUTHORISATION

16th October 1996 / 10th October 2001