- Approval Id
- ed04f085d1a1554f
- Drug Approval Emc Name
- Dermol 200 Shower Emollient
- Drug Name
- Dermol 200 Shower Emollient
- Company Address
- Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
- Company Website
- http://www.dermal.co.uk
- Company Telephone
- +44 (0)1462 458 866
- Legal Category
- Pharmacy
- Authorisation Holder
- Diomed Developments Limited
T/A Dermal Laboratories
Tatmore Place
Gosmore
Hitchin
Hertfordshire SG4 7QR
UK
- Authorisation Number
- PL 00173/0156
- Authorisation Date
- 21 February 1994 / 23 June 2009 (for 20/02/09 renewal date, PSUR-Renewal unlimited validity granted)
- Instruction Authorisation Holder
- Diomed Developments Limited
T/A Dermal Laboratories
Tatmore Place
Gosmore
Hitchin
Hertfordshire SG4 7QR
UK
- Instruction Authorisation Number
- PL 00173/0156
- Instruction Authorisation Date
- 21 February 1994 / 23 June 2009 (for 20/02/09 renewal date, PSUR-Renewal unlimited validity granted)
- Instruction Composition
- | | |
| --- | --- |
| Liquid Paraffin | 2.5% w/w |
| Isopropyl Myristate | 2.5% w/w |
| Benzalkonium Chloride | 0.1% w/w |
| Chlorhexidine Dihydrochloride | 0.1% w/w |
Excipients with known effect:
Cetostearyl alcohol
For the full list of excipients, see Section 6.1
- Instruction Dosage Form
- White, non-greasy \*\*CUTANEOUS EMULSION\*\*.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
An antimicrobial shower emollient for the management of dry and pruritic skin conditions, especially eczema and dermatitis. Dermol 200 Shower Emollient is for direct application onto the skin and is suitable for use as a soap substitute.4.2 Posology and method of administration
For adults, children and the elderly.
\*For application to the skin (e.g. after showering)\*
Apply to the affected areas as required.
Massage into the skin, until absorbed.
\*For use as a soap substitute in the shower\*
As required, use the shower emollient instead of ordinary shower gel or soap. Pat dry.4.3 Contraindications
Do not use in cases of known sensitivity (especially generalised allergic reaction) to any of the ingredients (see sections 4.4 and 4.8).4.4 Special warnings and precautions for use
Avoid contact with the eyes, especially when used on the face.
Take care to avoid slipping in the shower or bath, when using as a soap substitute.
Local skin reactions (e.g. contact dermatitis) to any of the ingredients are rare but possible in sensitive people.
There are literature reports of chlorhexidine compounds inducing hypersensitivity, including anaphylactic shock. The prevalence of this is not known, but is likely to be very rare. Dermol 200 Shower Emollient should not be administered to anyone with a possible history of allergic reaction to a chlorhexidine compound (see sections 4.3 and 4.8).
Dermol 200 Shower Emollient contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
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 known.4.6 Fertility, pregnancy and lactation
Use during pregnancy and lactation is not expected to be associated with harmful effects to the mother as cutaneous absorption of benzalkonium chloride is minimal. When breast-feeding, if use on the nipples is necessary, apply sparingly and after feeds. Gently wipe away any remaining product before feeding your baby.4.7 Effects on ability to drive and use machines
None known.4.8 Undesirable effects
Although the shower emollient has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction, discontinue treatment.
\*\*Local skin reactions\*\*
These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergic in nature. Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area.
\*\*Serious generalised allergic reactions\*\*
Very rarely, hypersensitivity including anaphylactic reaction (see sections 4.3 and 4.4) is possible (based on literature for chlorhexidine-containing products).
\*\*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
Not applicable.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Bacteria (especially \*Staphylococcus aureus\*) are implicated in the pathogenesis of inflammatory dry skin conditions such as atopic eczema and dermatitis.
Dermol 200 Shower Emollient contains 5% of emollient oils in a non-greasy aqueous system which also contains the well-known and effective antiseptics benzalkonium chloride and chlorhexidine dihydrochloride. Its antimicrobial properties assist in overcoming infection, whether from \*Staph aureus\*, the pathogen which often complicates eczema and associated pruritus, or secondary infection caused by scratching.
The emollients, liquid paraffin and isopropyl myristate, permit rehydration of dry skin by forming an occlusive barrier within the skin surface, thus reducing drying from evaporation of water that diffuses from the underlying layers.
Patients with dry skin conditions have a deficiency of the natural oils which assist in the retention of moisture.
A non-ionic emollient soap substitute such as Dermol 200 Shower Emollient, will cleanse the skin, helping to remove surface debris without removing the skin's natural oils.5.2 Pharmacokinetic properties
The active ingredients are presented in an aqueous emulsion system and so are readily absorbed into the stratum corneum when the product is gently massaged over the areas of dry skin. The antiseptic ingredients are in intimate contact with the skin, and as they are in solution, their availability is optimal.5.3 Preclinical safety data
No special information.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Cetostearyl alcohol
Macrogol cetostearyl ether (cetomacrogol)
Phenoxyethanol
Purified water6.2 Incompatibilities
None known6.3 Shelf life
15 months in unopened container6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
High density polyethylene \*\*BOTTLE\*\* (30, 50, 75, 100, 125, 150, 200, 250, 300, 350 or 500 ml) with either a white polypropylene \*\*METERING PUMP\*\* or a white polypropylene dispensing \*\*STOPPER/SCREW CAP\*\*. A polypropylene hooked overcap is provided on some pack sizes.
Paper/polyethylene/foil/polyethylene laminate \*\*SACHET\*\* (5 or 10 ml) packaged into unit cartons in appropriate multiples to match the above bottle capacities.
Supplied as original packs (OP).6.6 Special precautions for disposal and other handling
Not applicable.
- Instruction Content
- ## Composition
| | |
| --- | --- |
| Liquid Paraffin | 2.5% w/w |
| Isopropyl Myristate | 2.5% w/w |
| Benzalkonium Chloride | 0.1% w/w |
| Chlorhexidine Dihydrochloride | 0.1% w/w |
Excipients with known effect:
Cetostearyl alcohol
For the full list of excipients, see Section 6.1
## Pharmaceutical Form
White, non-greasy \*\*CUTANEOUS EMULSION\*\*.
## Clinical Particulars
4.1 Therapeutic indications
An antimicrobial shower emollient for the management of dry and pruritic skin conditions, especially eczema and dermatitis. Dermol 200 Shower Emollient is for direct application onto the skin and is suitable for use as a soap substitute.4.2 Posology and method of administration
For adults, children and the elderly.
\*For application to the skin (e.g. after showering)\*
Apply to the affected areas as required.
Massage into the skin, until absorbed.
\*For use as a soap substitute in the shower\*
As required, use the shower emollient instead of ordinary shower gel or soap. Pat dry.4.3 Contraindications
Do not use in cases of known sensitivity (especially generalised allergic reaction) to any of the ingredients (see sections 4.4 and 4.8).4.4 Special warnings and precautions for use
Avoid contact with the eyes, especially when used on the face.
Take care to avoid slipping in the shower or bath, when using as a soap substitute.
Local skin reactions (e.g. contact dermatitis) to any of the ingredients are rare but possible in sensitive people.
There are literature reports of chlorhexidine compounds inducing hypersensitivity, including anaphylactic shock. The prevalence of this is not known, but is likely to be very rare. Dermol 200 Shower Emollient should not be administered to anyone with a possible history of allergic reaction to a chlorhexidine compound (see sections 4.3 and 4.8).
Dermol 200 Shower Emollient contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
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 known.4.6 Fertility, pregnancy and lactation
Use during pregnancy and lactation is not expected to be associated with harmful effects to the mother as cutaneous absorption of benzalkonium chloride is minimal. When breast-feeding, if use on the nipples is necessary, apply sparingly and after feeds. Gently wipe away any remaining product before feeding your baby.4.7 Effects on ability to drive and use machines
None known.4.8 Undesirable effects
Although the shower emollient has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction, discontinue treatment.
\*\*Local skin reactions\*\*
These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergic in nature. Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area.
\*\*Serious generalised allergic reactions\*\*
Very rarely, hypersensitivity including anaphylactic reaction (see sections 4.3 and 4.4) is possible (based on literature for chlorhexidine-containing products).
\*\*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
Not applicable.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Bacteria (especially \*Staphylococcus aureus\*) are implicated in the pathogenesis of inflammatory dry skin conditions such as atopic eczema and dermatitis.
Dermol 200 Shower Emollient contains 5% of emollient oils in a non-greasy aqueous system which also contains the well-known and effective antiseptics benzalkonium chloride and chlorhexidine dihydrochloride. Its antimicrobial properties assist in overcoming infection, whether from \*Staph aureus\*, the pathogen which often complicates eczema and associated pruritus, or secondary infection caused by scratching.
The emollients, liquid paraffin and isopropyl myristate, permit rehydration of dry skin by forming an occlusive barrier within the skin surface, thus reducing drying from evaporation of water that diffuses from the underlying layers.
Patients with dry skin conditions have a deficiency of the natural oils which assist in the retention of moisture.
A non-ionic emollient soap substitute such as Dermol 200 Shower Emollient, will cleanse the skin, helping to remove surface debris without removing the skin's natural oils.5.2 Pharmacokinetic properties
The active ingredients are presented in an aqueous emulsion system and so are readily absorbed into the stratum corneum when the product is gently massaged over the areas of dry skin. The antiseptic ingredients are in intimate contact with the skin, and as they are in solution, their availability is optimal.5.3 Preclinical safety data
No special information.
## Pharmaceutical Particulars
6.1 List of excipients
Cetostearyl alcohol
Macrogol cetostearyl ether (cetomacrogol)
Phenoxyethanol
Purified water6.2 Incompatibilities
None known6.3 Shelf life
15 months in unopened container6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
High density polyethylene \*\*BOTTLE\*\* (30, 50, 75, 100, 125, 150, 200, 250, 300, 350 or 500 ml) with either a white polypropylene \*\*METERING PUMP\*\* or a white polypropylene dispensing \*\*STOPPER/SCREW CAP\*\*. A polypropylene hooked overcap is provided on some pack sizes.
Paper/polyethylene/foil/polyethylene laminate \*\*SACHET\*\* (5 or 10 ml) packaged into unit cartons in appropriate multiples to match the above bottle capacities.
Supplied as original packs (OP).6.6 Special precautions for disposal and other handling
Not applicable.
- Company Detail Path
- /organization/dermal-laboratories-limited
