DEEP FREEZE CUTANEOUS SPRAY SOLUTION

Main information

  • Trade name:
  • DEEP FREEZE CUTANEOUS SPRAY SOLUTION
  • Pharmaceutical form:
  • Cutaneous Spray Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DEEP FREEZE CUTANEOUS SPRAY SOLUTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0076/001/001
  • Authorization date:
  • 24-10-1989
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DeepFreezeCutaneousSpray Solution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Cutaneousspray solution.

Apressurized aerosol, multi-dosedispenser

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthesymptomaticreliefofmuscularpain

4.2Posologyandmethodofadminstration

Foradultsand children over6 years

Theusualdoseis2 to 3 jetsat30 second intervalsto amaximumof3 treatmentsdaily. Thecontainershould beheld

6 inchesfromtheaffected areasand used for3to 5 secondsonly.

Avoid excessiveuse.

Children under6 years

Notto beused on children under6 yearsofage.

4.3Contraindications

Noneknown.

4.4Special warningsandspecialprecautionsforuse

Do notuseon broken orinflamed skin. Avoiduseon head, digitsorsensitiveareas. When used neartheface, theeyes,

nostrilsand mouth should beadequately screened. Application should becarried outin awell-ventilated space.

Inhalation should beavoided. Ifsymptomspersist, consultyourdoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Levomenthol 2.00%w/w

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 21/09/2005 CRN 2014923 page number: 1

4.6Pregnancyandlactation

Notapplicable

4.7Effectsonabilitytodriveandusemachines

Noneknown

4.8Undesirableeffects

Noneknown

4.9Overdose

Notapplicable

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

When pentaneimpingeson theskin itevaporatesand causesacooling sensation. Menthol, when applied topically,

causesasensation ofcold followed by analgesia, which iscomforting in thereliefofmuscularpain. Thefeeling of

comfortwhen thespray isofbenefitto thepatient.

5.2Pharmacokineticproperties

Notapplicable

5.3Preclinical safetydata

No safety issuesbecameevidentduring thecourseofthesestudies

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Dimethylether

Ethanol

6.2Incompatibilities

Notapplicable

6.3ShelfLife

3 years

6.4Special precautionsforstorage

Do notstoreabove25 o

Irish Medicines Board

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Date Issued 21/09/2005 CRN 2014923 page number: 2

6.5Natureandcontentsofcontainer

Tinplateaerosolcan internally plain filled to 135g.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

TheMentholatumCompany Limited

1 Redwood Avenue

PeelPark Campus

EastKilbride

G74 5PF

Scotland

8MARKETINGAUTHORISATIONNUMBER

PA76/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:24 th

October1989

Dateoflastrenewal:24 th

October2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 21/09/2005 CRN 2014923 page number: 3