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DERMALO BATH EMOLLIENT - summary of medicine characteristics

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Summary of medicine characteristics - DERMALO BATH EMOLLIENT

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

1 NAME OF THE MEDICINAL PRODUCT

Dermalo Bath Emollient

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Liquid Paraffin

65.0% w/w

5.0% w/w

Acetylated Wool Alcohols

3. PHARMACEUTICAL FORM

BATH ADDITIVE

Dye- and fragrance-free colourless to straw coloured clear oily liquid.

4. CLINICAL PARTICULARS

4.1. Therapeutic Indications

For the symptomatic relief of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin disorders.

4.2. Posology and Method of Administration

Adults, including the elderly:

Add 15 to 20 ml (m to 2 capfuls) to a standard bath of water (8 inch depth). Immerse and cover the affected areas with the bath water and soak for 10 to 20 minutes. Pat dry with a towel. Alternatively, use a similar amount smoothed onto wet skin following a shower. Rinse off thoroughly and pat dry with a towel.

Infants and children:

Add 5 to 10 ml (^ to 1 capful) to a small bath or wash basin of water.

Immerse and cover the affected areas with the bath water and soak for 10 to 20 minutes. Alternatively, repeatedly gently sponge over the affected areas. Pat dry with a towel.

There is no differentiation between the dosage quantities for the symptomatic relief of the conditions listed.

4.3. Contra-Indications

Sensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

Take care not to slip in the bath or shower. Surfaces that have been in contact with the product should be cleaned with a proprietary detergent. Keep out of the sight and reach of children. For external use only.

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. Pregnancy and Lactation

The constituents are not percutaneously absorbed or toxic if ingested. There is no evidence of safety of the drug used in pregnancy or lactation, but the active constituents have been in widespread use and in similar preparations for many years without apparent ill consequence.

4.7. Effects on Ability to Drive and Use Machines

None known.

4.8 Undesirable effects

Contact sensitivity reactions or mild irritant reactions may occur occasionally. In either case, treatment should be discontinued.

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.

4.9. Overdose

Accidental ingestion may result in a purgative action due to the liquid paraffin and the oily nature of the product. Treat symptomatically. Fluid and electrolyte replacement may be necessary.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

For dry skin conditions it is important to use an emollient while bathing. Dermalo Bath Emollient contains 65% Liquid Paraffin and 5% Acetylated Wool Alcohols for their moisturising and skin softening properties, and is specially formulated to facilitate dispersion in bath water or for ease of application after a shower.

5.2. Pharmacokinetic Properties

The active constituents are not absorbed percutaneously. Pharmacokinetic particulars are thus not relevant.

5.3. Preclinical Safety Data

5.3. Preclinical Safety Data

No relevant information additional to that contained elsewhere in the SPC.

PHARMACEUTICAL PARTICULARSPHARMACEUTICAL PARTICULARS

6.1

List of excipients

Isopropyl myristate

Macrogol isotridecyl ether

6.2. Incompatibilities

None known.

6.3. Shelf Life

36 months in unopened container.

6.4. Special Precautions for Storage

Do not store above 25oC.

6.5. Nature and Contents of Container

50, 200, 500 or 1000 ml white high density polyethylene BOTTLE fitted with a polyethylene dispensing plug and spigotted polypropylene SCREW CAP.

Supplied in original packs (OP).

6.6. Instruction for Use, Handling and Disposal

Not applicable.

7. MARKETING AUTHORISATION HOLDER

Diomed Developments Limited

T/A Dermal Laboratories

Tatmore Place

Gosmore

Hitchin

Hertfordshire SG4 7QR

United Kingdom

8. MARKETING AUTHORISATION NUMBER

8. MARKETING AUTHORISATION NUMBER

PL 00173/0182

9. DATE OF FIRST AUTHORISATION/RE­NEWAL OF AUTHORISATION

14 February 2000