- Approval Id
- 161db85a16cfd960
- Drug Approval Emc Name
- Dermol 500 Lotion
- Drug Name
- Dermol 500 Lotion
- Company Address
- Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
- Company Website
- http://www.dermal.co.uk
- Company Telephone
- +44 (0)1462 458 866
- Atc Code
- D02AX
- Legal Category
- Pharmacy
- Authorisation Holder
- Diomed Developments Limited
T/A Dermal Laboratories
Tatmore Place
Gosmore
Hitchin
Hertfordshire SG4 7QR
UK
- Authorisation Number
- PL 00173/0051
- Authorisation Date
- 16 January 1991 / 23 June 2009 (for 01/10/07 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 00173/0051
- Instruction Authorisation Date
- 16 January 1991 / 23 June 2009 (for 01/10/07 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
- Cutaneous Emulsion
White, non-greasy cutaneous emulsion
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
An antimicrobial emollient for the management of dry and pruritic skin conditions, especially eczema and dermatitis. The lotion is suitable for direct application, and for use as a soap substitute.4.2 Posology and method of administration
For adults, children and the elderly.
\*For application to the skin\*
Apply the lotion to the affected areas as required.
Massage into the skin, until absorbed.
\*For use as a soap substitute\*
Use as a cleanser in the bath or shower, or for other toiletry purposes, instead of ordinary soap or shower gel.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.
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 500 Lotion 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 500 Lotion 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 lotion 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 Store4.9 Overdose
Not applicable.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
ATC code: D02 AX, emollients and protectives.
Bacteria (especially Staphylococcus aureus) are implicated in the pathogenesis of inflammatory dry skin conditions such as atopic eczema or dermatitis.
Dermol 500 Lotion contains 5% of emollient oils in a non-greasy aqueous lotion 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.
Massaged into the skin, 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.5.2 Pharmacokinetic properties
The active ingredients are presented in an aqueous lotion 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 container (all pack sizes)6.4 Special precautions for storage
Do not store above 25°C.
Replace cap after use.6.5 Nature and contents of container
High density polyethylene \*\*BOTTLE\*\* (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/CAP\*\* as appropriate.
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
No special requirements.
- 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
Cutaneous Emulsion
White, non-greasy cutaneous emulsion
## Clinical Particulars
4.1 Therapeutic indications
An antimicrobial emollient for the management of dry and pruritic skin conditions, especially eczema and dermatitis. The lotion is suitable for direct application, and for use as a soap substitute.4.2 Posology and method of administration
For adults, children and the elderly.
\*For application to the skin\*
Apply the lotion to the affected areas as required.
Massage into the skin, until absorbed.
\*For use as a soap substitute\*
Use as a cleanser in the bath or shower, or for other toiletry purposes, instead of ordinary soap or shower gel.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.
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 500 Lotion 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 500 Lotion 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 lotion 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 Store4.9 Overdose
Not applicable.
## Pharmacological Properties
5.1 Pharmacodynamic properties
ATC code: D02 AX, emollients and protectives.
Bacteria (especially Staphylococcus aureus) are implicated in the pathogenesis of inflammatory dry skin conditions such as atopic eczema or dermatitis.
Dermol 500 Lotion contains 5% of emollient oils in a non-greasy aqueous lotion 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.
Massaged into the skin, 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.5.2 Pharmacokinetic properties
The active ingredients are presented in an aqueous lotion 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 container (all pack sizes)6.4 Special precautions for storage
Do not store above 25°C.
Replace cap after use.6.5 Nature and contents of container
High density polyethylene \*\*BOTTLE\*\* (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/CAP\*\* as appropriate.
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
No special requirements.
- Company Detail Path
- /organization/dermal-laboratories-limited
