DEEP FREEZE CUTANEOUS SPRAY SOLUTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-04-2024
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Active ingredient:
PENTANE LEVOMENTHOL
Available from:
The Mentholatum Company Ltd.
Pharmaceutical form:
Cutaneous Spray Solution
Authorization date:
1989-10-24
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Deep Freeze Cutaneous Spray Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cutaneous spray solution.
A pressurized aerosol, multi-dose dispenser
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of muscular pain
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For adults and children over 6 years
The usual dose is 2 to 3 jets at 30 second intervals to
a maximum of 3 treatments daily. The container should be held
6 inches from the affected areas and used for 3 to 5
seconds only.
Avoid excessive use.
Children under 6 years
Not to be used on children under 6 years of age.
4.3 CONTRAINDICATIONS
None known.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Do not use on broken or inflamed skin. Avoid use on head,
digits or sensitive areas. When used near the face, the eyes,
nostrils and mouth should be adequately screened. Application should
be carried out in a well-ventilated space.
Inhalation should be avoided. If symptoms persist,
consult your doctor.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None known
Levomenthol
2.00%w/w
n-Pentane
40.00%w/w
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 21/09/2005_
_CRN 2014923_
_page number: 1_
4.6 PREGNANCY AND LACTATION
Not applicable
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known
4.8 UNDESIRABLE EFFECTS
None known
4.9 OVERDOSE
Not applicable
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
When pentane impinges on the skin it evaporates and
causes a cooling sensation.
Menthol, when applied topically,
causes a sensation of cold followed by analgesia, which
is comforting in the relief of muscular pain. The
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