Emollient Bath Oil
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emollient Bath Oil
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Light Liquid Paraffin 63.4% w/w
3. PHARMACEUTICAL FORM
Bath oil
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Emollient Bath Oil is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritus ichthyosis and related dry skin conditions. Emollient Bath Oil deposits a thin film of oil over the skin. This retards moisture loss and hydrates the skin. Emollient Bath Oil is particularly suitable for infant bathing. The preparation also overcomes the problem of cleansing the skin in conditions where the use of soaps, soap substitutes and colloid or oat-meal baths proves irritating.
4.2. Posology and Method of Administration
Emollient Bath Oil should always be used with water, either added to water or applied to wet skin.
Adult Bath: Add V - 1V capfuls to an 8 inch bath of water. Soak for 10-20 minutes. Pat dry.
Infant Bath: Add 'A - 1 capful to a basin of water. Apply gently over entire body with a sponge. Pat dry.
Skin cleansing: Rub a small amount of oil into wet skin. Rinse and pat dry.
Where conditions permit, and particularly in cases of extensive areas of dry skin, Emollient Bath Oil should be used as a bath oil, ensuring complete coverage by immersion. In addition to the therapeutic benefits, this method of use provides a means of sedating tense patients, particularly relevant in cases of acute pruritic dermatoses where relaxation of tension appears to relieve symptoms. The product is suitable for use in adults, children and the elderly.
4.3. Contra-Indications
Do not use on individuals with hypersensitivity to any of the ingredients.
4.4. Special Warning and Precautions for Use
If a rash or skin irritation occurs, stop using this product and consult your doctor.
Care should be taken against slipping especially when entering or leaving the bath or shower.
For external use only.
Keep all medicines out of the sight and reach of children.
4.5. Interaction with other Medicinal Products and other Forms of Interaction
No significant interactions are known.
4.6 Fertility, pregnancy and lactation Fertility
There are no data on the use of Light Liquid Paraffin on human fertility. Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to Light Liquid Paraffin is expected to be low.
Lactation
It is not known if Light Liquid Paraffin is excreted in human milk. Risk to the infant is likely to be low since systemic exposure is low. Patients should be advised to ensure that any residual product is fully washed off the breast prior to breast feeding.
4.7. Effects on Ability to Drive and Use Machines
None would be anticipated.
4.8 Undesirable effects
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (>1/10), common (>1/100 and <1/10), uncommon (>1/1,000 and < 1/100), rare (>1/10, 000 and <1/1,000); very rare (<1/10, 000) and not known (cannot be estimated from the available data).No significant effects have been reported with topical use.
Post-marketing data
|
System Organ Class |
Frequency - rare |
|
Immune system disorders |
Application site hypersensitivity reactions including application site dermatitis |
|
Skin and subcutaneous tissue disorders |
Application site reactions including application site irritation, rash, erythema, pruritus |
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
Signs and symptoms
The product is intended for cutaneous use only. Accidental ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea.
Treatment
In case of accidental ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available.
5.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
5.1.
Light Liquid Paraffin is a lubricant and emollient. It forms an occlusive film on the skin retarding water loss from the stratum corneum and aiding in the prevention of dryness.
5.2. Pharmacokinetic Properties
Little information is available on the pharmacokinetics of light liquid paraffin. Intestinal absorption of small amounts may occur. It is not metabolised.
5.3. Pre-clinical Safety Data
No relevant data are available.
6. PHARMACEUTICAL PARTICULARS 6.1. List of Excipients
Isopropyl Myristate B.P.
Polyethoxylated (3) Lauryl Alcohol HSE.
Perfume C2106 HSE.
6.2. Incompatibilities
No significant incompatibilities are known.
6.3. Shelf-Life
Two years.
6.4. Special Precautions for Storage
Store below 25°C.
6.5. Nature and Contents of Container
A rectangular white HDPE bottle fitted with a ridged white HDPE screw-cap closure with an expanded polyethylene (EPE) liner.
Pack sizes: 250ml & 500ml.
Not all pack sizes may be marketed.
6.6. Instructions for Use, Handling and Disposal
No further information.
7. MARKETING AUTHORISATION HOLDER
Manx Healthcare Limited 1 Hawkes Drive Heathcote Industrial Estate Warwick CV34 5YA United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 14251/0019
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29 October 2003/28 May 2008
15/03/2015