- Approval Id
- 1af09dcb636a6dfa
- Drug Approval Emc Name
- Dermamist
- Drug Name
- Dermamist
- Company Address
- Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB
- Company Website
- http://www.alliancepharma.co.uk
- Company Telephone
- +44 (0)1249 466 966
- Company Medical Info Email
- medinfo@alliancepharma.co.uk
- Legal Category
- Pharmacy
- Authorisation Holder
- Alliance Pharmaceuticals Limited
Avonbridge House
Bath Road
Chippenham
Wiltshire
England
SN15 2BB
- Authorisation Number
- PL 16853/0098
- Authorisation Date
- 15/03/94
- Instruction Authorisation Holder
- Alliance Pharmaceuticals Limited
Avonbridge House
Bath Road
Chippenham
Wiltshire
England
SN15 2BB
- Instruction Authorisation Number
- PL 16853/0098
- Instruction Authorisation Date
- 15/03/94
- Instruction Composition
- White Soft Paraffin BP 10.0% w/w.
- Instruction Dosage Form
- Pressurised aerosol
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Treatment of dry skin conditions including eczema, ichthyosis and pruritus of the elderly.4.2 Posology and method of administration
Adults, children and the elderly: Shake before use. Bathe or shower for not more than ten minutes. Pat dry and apply spray without delay. Do not spray on face. Spray from a distance of approximately 8 inches. Spray away from the face and move the can while spraying to achieve a very light coverage of the body. Spray sparingly; over application may cause the skin to feel oily.4.3 Contraindications
Hypersensitivity to any of the ingredients.4.4 Special warnings and precautions for use
For external use only. Keep out of reach of children. Do not spray on face. Use in a ventilated area. Avoid inhalation. Guard against slipping. Discontinue use if the condition is made worse. Do not apply to broken skin.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.4.5 Interaction with other medicinal products and other forms of interaction
None.4.6 Pregnancy and lactation
Can be used.4.7 Effects on ability to drive and use machines
Not relevant.4.8 Undesirable effects
May cause contact dermatitis
\*\*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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
None
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Emollients are fats or oils used for their local action on the skin and, occasionally, the mucous membranes. These oleaginous substances, also known as occlusive agents and humectants, are employed as protectives and as agents for softening the skin and rendering it more pliable. White soft paraffin forms an effective occlusive lipid film. The mechanism of action is by occluding water loss from the outer layer of skin.5.2 Pharmacokinetic properties
White soft paraffin exerts its physiological effects by forming an occlusive layer on the surface of the skin. It is effective because it is not subject to absorption or subsequent distribution in the body, excretion or metabolism. Pharmacokinetic particulars are not appropriate in these circumstances.5.3 Preclinical safety data
No relevant pre-clinical data has been generated.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Liquid paraffin BP
Fractionated coconut oil BP
Butane 40 (butane: isobutane: propane) HSE6.2 Incompatibilities
None6.3 Shelf life
60 months.6.4 Special precautions for storage
Store below 25° C. Pressurised container. Highly flammable, Protect from sunlight and do not puncture, burn or expose to temperatures over 50° C even when empty. Do not spray on a naked flame or any incandescent material.6.5 Nature and contents of container
Pressurised aerosol. Pack sizes 50 ml, 250 ml, 75 ml, 150 ml, 200 ml, 300 ml, 400 ml, and 500 ml.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special instructions for use or handling.
- Instruction Content
- ## Composition
White Soft Paraffin BP 10.0% w/w.
## Pharmaceutical Form
Pressurised aerosol
## Clinical Particulars
4.1 Therapeutic indications
Treatment of dry skin conditions including eczema, ichthyosis and pruritus of the elderly.4.2 Posology and method of administration
Adults, children and the elderly: Shake before use. Bathe or shower for not more than ten minutes. Pat dry and apply spray without delay. Do not spray on face. Spray from a distance of approximately 8 inches. Spray away from the face and move the can while spraying to achieve a very light coverage of the body. Spray sparingly; over application may cause the skin to feel oily.4.3 Contraindications
Hypersensitivity to any of the ingredients.4.4 Special warnings and precautions for use
For external use only. Keep out of reach of children. Do not spray on face. Use in a ventilated area. Avoid inhalation. Guard against slipping. Discontinue use if the condition is made worse. Do not apply to broken skin.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.4.5 Interaction with other medicinal products and other forms of interaction
None.4.6 Pregnancy and lactation
Can be used.4.7 Effects on ability to drive and use machines
Not relevant.4.8 Undesirable effects
May cause contact dermatitis
\*\*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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
None
## Pharmacological Properties
5.1 Pharmacodynamic properties
Emollients are fats or oils used for their local action on the skin and, occasionally, the mucous membranes. These oleaginous substances, also known as occlusive agents and humectants, are employed as protectives and as agents for softening the skin and rendering it more pliable. White soft paraffin forms an effective occlusive lipid film. The mechanism of action is by occluding water loss from the outer layer of skin.5.2 Pharmacokinetic properties
White soft paraffin exerts its physiological effects by forming an occlusive layer on the surface of the skin. It is effective because it is not subject to absorption or subsequent distribution in the body, excretion or metabolism. Pharmacokinetic particulars are not appropriate in these circumstances.5.3 Preclinical safety data
No relevant pre-clinical data has been generated.
## Pharmaceutical Particulars
6.1 List of excipients
Liquid paraffin BP
Fractionated coconut oil BP
Butane 40 (butane: isobutane: propane) HSE6.2 Incompatibilities
None6.3 Shelf life
60 months.6.4 Special precautions for storage
Store below 25° C. Pressurised container. Highly flammable, Protect from sunlight and do not puncture, burn or expose to temperatures over 50° C even when empty. Do not spray on a naked flame or any incandescent material.6.5 Nature and contents of container
Pressurised aerosol. Pack sizes 50 ml, 250 ml, 75 ml, 150 ml, 200 ml, 300 ml, 400 ml, and 500 ml.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special instructions for use or handling.
- Company Detail Path
- /organization/alliance-pharmaceuticals
