Deep Freeze Cold Gel 2%W/W.
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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).
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 of suspected adverse reactions:
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.
PHARMACEUTICAL PARTICULARS
6.
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
10 DATE OF REVISION OF THE TEXT
29/05/2015