Oilatum Junior Bath Additive

Oilatum Junior is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin conditions.

Route of administration: Topical

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 ½ -2 capfuls to a basin of water. Apply gently over entire body with a sponge. Pat dry.

None.

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.

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.

None known.

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.

None.

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

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.

Treatment

In case of accidental ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available.

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.

Not applicable.

None.

Acetylated Lanolin Alcohols

Isopropyl Palmitate

Polyethylene Glycol 400 dilaurate

Macrogol ester.

Not applicable.

For the product as packaged for sale: 5 years.

None.

High density polyethylene bottles with a screw cap. Capacity: 25ml, 150ml, 200ml, 250ml, 300ml, 350ml, 400ml, 500ml, 600ml, 1000ml.

There are no special instructions for use or handling of Oilatum Junior.