1. Name of the medicinal product
2. Qualitative and quantitative composition
Light Liquid Paraffin 63.4% w/w
Excipient(s) with known effect
Acetylated Lanolin Alcohol
Fragrance (Contains: geraniol, linalool, coumarin, limonene, citronellol, eugenol, hydroxycitronellal and hexyl cinnamaldehyde)
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Liquid Bath Additive
4. Clinical particulars
4.1 Therapeutic indications
Oilatum Emollient is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin conditions. Oilatum Emollient replaces oil and water and hydrates the keratin. Oilatum Emollient 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 oatmeal baths proves irritating.
4.2 Posology and method of administration
Oilatum Emollient should always be used with water, either added to the water or applied to wet skin.
Add 1-3 capfuls to an 8-inch bath of water, soak for 10-20 minutes. Pat dry.
Add ½-2 capfuls to a basin of water, Apply gently over entire body with a sponge. Pat dry.
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, Oilatum Emollient 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.
4.4 Special warnings and precautions for use
The patient should be advised to use care to avoid slipping in the bath. If a rash or skin irritation occurs, stop using the product and consult your doctor.
Oilatum Emollient should be used with caution in patients with a known sensitivity or allergy to light liquid paraffin (LLP) or to any of the excipients in the preparation.
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. This medicinal product contains Lanolin which may cause local skin reactions (e.g. contact dermatitis).
This medicine contains fragrance with geraniol, linalool, coumarin, limonene, citronellol, eugenol, hydroxycitronellal and hexyl cinnamaldehyde which may cause allergic reactions.”
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
There are no data on the use of Oilatum Emollient on human fertility.
No effects during pregnancy are anticipated, since systemic exposure to Oilatum Emollient is expected to be low.
It is not known if Oilatum Emollient 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
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).
Skin and Subcutaneous Tissue Disorders
Rare: Application site reactions including application site irritation, rash, erythema, pruritus
Immune System Disorders
Rare: Application site hypersensitivity reactions including application site 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.
Symptoms and signs
The product is intended for cutaneous use only. Accidental ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea.
In case of accidental ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Light liquid paraffin exerts an emollient effect by forming an occlusive oil film on the stratum corneum. This prevents excessive evaporation of water from the skin surface and aids in the prevention of dryness.
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
Acetylated Lanolin Alcohols
Polyethylene Glycol 400 dilaurate
Polyoxyethylene 40 sorbital septaoleate
Fragrance (geraniol, linalool, coumarin, limonene, citronellol, eugenol, hydroxycitronellal and hexyl cinnamaldehyde)
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
High density polyethylene bottles with a screw cap. Capacity: 25ml, 150ml, 200ml, 250ml, 300ml, 350ml, 400ml, 500ml, 600ml, 1000ml.
6.6 Special precautions for disposal and other handling
There are no special instructions for use or handling.