Oilatum Emollient
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oilatum Junior
Oilatum Emollient Fragrance Free
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Light Liquid paraffin BP 63.4% w/w.
3 PHARMACEUTICAL FORM
Liquid bath additive.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Oilatum Junior is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin conditions.
Route of administration: Topical
4.2 Posology and method of administration
Oilatum Junior may be used as frequently as necessary. Oilatum Junior should always be used with water, either added to the water or applied to wet skin.
For adults add 1-3 capfuls to an 8 inch bath of water. Soak for 10-20 minutes. Pat dry.
For infants, add ‘A-2 capfuls to a basin of water. Apply gently over entire body with a sponge. Pat dry.
4.3 Contraindications
None.
4.4 Special warnings and precautions for use
Patients should be advised to use care to avoid slipping in the bath. If a rash or skin irritation should occur, stop using the product and consult your doctor.
Oilatum Junior 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.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation Fertility
There are no data on the use of Oilatum Junior on human fertility.
Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to Oilatum Junior is expected to be low.
Lactation
It is not known if Oilatum Junior 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.
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).
Post-marketing 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
4.9 Overdose
Symptoms and signs
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
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
Not applicable.
5.3
Preclinical safety data
None.
6.1 List of excipients
Acetylated Lanolin Alcohols Isopropyl Palmitate Polyethylene Glycol 400 dilaurate Macrogol ester.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
For the product as packaged for sale: 5 years.
6.4 Special precautions for storage
None.
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
There are no special instructions for use or handling of Oilatum Junior.
7
MARKETING AUTHORISATION HOLDER
Beecham Group plc, trading as Stiefel
980 Great West Road Brentford Middlesex TW8 9GS United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00079/0708
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
June 1993.
10 DATE OF REVISION OF THE TEXT
20/02/2014