OILATUM PLUS, OILATUM ANTISEPTIC BATH EMOLLIENT, OILATUM JUNIOR FLARE-UP

For cutaneous use only. Oilatum Plus must always be used diluted in water. It is an effective cleanser and should not be used with soap. Use once daily.

Do not exceed the recommended dose:

Adults, adolescents and children:In an eight inch bath (20 cm) add 2 capfuls (20 ml); in a four inch (10 cm) bath add 1 capful (10 ml). Mix well. Soak for 10-15 minutes. Gently pat the skin dry with a clean towel.

Infants over 6 months of age:

Add 1 ml (just sufficient to cover the bottom of the cap) to a baby bath containing approximately 15 litres of water and mix well. Soak for 10-15 minutes. Gently pat the skin dry with a clean towel. The safety and efficacy of Oilatum Plus has not been established in children less than 6 months of age.

Oilatum Plus is not recommended for use in children under 6 months of age.

Elderly:

No dosage adjustment is required in the elderly.

Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as not known (cannot be estimated from the available data).

Post-marketing data Skin and subcutaneous tissues disorders Not Known:

Application site reactions including- skin exfoliation, erythema, dermatitis, pruritus and burning sensation.

Immune System disorders Not known:

Application site hypersensitivity 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.

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Oilatum Plus contains benzalkonium chloride which is irritant and may cause skin reactions. g. contact dermatitis). Keep out of reach and sight of children. If irritation or rash occurs when the product is used in the correct dilution, use should be discontinued.

If the undiluted product comes into contact with the eye, reddening may occur. The patient should be advised to perform eye irrigation for 15 minutes. If there is persistent irritation the patient should be advised to contact a doctor.

Avoid contact of the undiluted product with the eyes and skin. If undiluted product is applied directly to the skin, it may cause application site skin irritation and hypersensitivity reactions including skin exfoliation, pain, blister, caustic injury and necrosis.

The patient should be advised to contact a doctor. The patient should be advised to use care to avoid slipping in the bath. 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.

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