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Oilatum Junior Cream

Last Updated on eMC 09-Apr-2014 View changes  | GlaxoSmithKline Consumer Healthcare Contact details

1. Name of the medicinal product

Oilatum Junior Cream

2. Qualitative and quantitative composition

Contains Light Liquid Paraffin 6.0% w/w and White Soft Paraffin 15.0% w/w in a cream base.

Also contains cetostearyl alcohol and potassium sorbate.

For a full list of excipients, see Section 6.1.

3. Pharmaceutical form

Cream.

A white to off-white cream.

4. Clinical particulars
4.1 Therapeutic indications

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

4.2 Posology and method of administration

Oilatum Junior Cream may be used as often as required. Apply to the affected area and rub in well. It is especially effective after washing when the sebum content of the stratum corneum may be depleted resulting in excessive moisture loss.

Oilatum Junior Cream is suitable for adults, children and the elderly.

4.3 Contraindications

PL 00079/0705: None.

PL 00079/0706: Should not be used in patients with known hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

Oilatum Junior Cream should be used with caution in patients with a known sensitivity or allergy to white soft paraffin or light liquid paraffin (WSP-LLP) or to any of the excipients in the preparation.

Cetostearyl alcohol and potassium sorbate may cause local skin reactions (e.g. contact dermatitis).

PL 00079/0705: Hospital users should follow local procedures and policies for using topical products on in-patients.

4.5 Interaction with other medicinal products and other forms of interaction

None.

4.6 Pregnancy and lactation

There are no restrictions on the use of Oilatum Junior Cream during pregnancy or lactation.

Fertility

There are no data on the use of topical Oilatum Junior Cream on human fertility

Pregnancy

There are no data on the use of topical Oilatum Junior Cream in pregnant women. No effects during pregnancy are anticipated, since systemic exposure to WSP/LLP is low.

Lactation

It is not known if Oilatum Junior Cream 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

May cause irritation in patients hypersensitive to any of the ingredients.

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 erythema, rash, pain, pruritus, skin burning sensation.

Immune System Disorders

Rare: Application site hypersensitivity reactions including application site dermatitis.

4.9 Overdose

Symptoms and signs

The product is intended for topical use only. Ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea. Excessive topical application should cause no untoward effects other than greasy skin.

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 and White Soft Paraffin exert an emollient effect by forming an occlusive film which reduces trans-epidermal water loss, thus helping to maintain normal skin humidity levels. Polyvinyl pyrrolidone enhances the strength and longevity of the occlusive film formed by the oil on the skin.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

White Soft Paraffin and Light Liquid Paraffin have been used in pharmaceutical and cosmetic preparations for many years. The formulation contains excipients that are commonly used in such preparations. The safety of these substances is well established by common use over long periods in man.

6. Pharmaceutical particulars
6.1 List of excipients

Macrogol 1000 Monostearate

Cetostearyl alcohol

Glycerol

Potassium sorbate

Benzyl alcohol

Citric acid monohydrate

Povidone

Purified water

6.2 Incompatibilities

None.

6.3 Shelf life

Pack sizes 25g, 30g 40g, 50g, 80g, 100g and 150g: Three years

Pack sizes 350ml, 500ml, 1000ml, 1050ml, 1100ml and 1150ml: 30 Months

6.4 Special precautions for storage

Store below 25 °C

6.5 Nature and contents of container

Internally lacquered, membrane sealed aluminium tube fitted with a polypropylene screw cap and packed into a carton. Pack size 40g and 80g.

Internally lacquered, membrane sealed aluminium tube fitted with a polyethylene screw cap and packed into a carton. Pack size 30g and 50g.

Laminate tubes with polypropylene caps packed into cartons: Pack sizes 100g and 150g.

And 25g, 50g and 150g in a high density polyethylene tube.

350ml and 500ml pump pack: high density polyethylene bottle fitted with a mechanical pump dispenser (polyethylene/ polypropylene components).

1000ml, 1050ml, 1100ml and 1150ml pump pack: polypropylene container and lid, fitted with a mechanical pump dispenser (polypropylene components), utilising a follower plate (HDPE).

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

None.

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)

Pack sizes 25g, 30g, 40g, 50g, 80g, 100g and 150g: PL 00079/0706

Pack sizes 350ml, 500ml, 1000ml, 1050ml, 1100ml and 1150ml: PL 00079/0705

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation PL 00079/0706: 24th January 2001/7 December 2010

Date of first authorisation PL 00079/0705: 28th October 2005

10. Date of revision of the text

PL 00079/0705: 20/2/14

PL 00079/0706: 25/3/14

Company contact details

GlaxoSmithKline Consumer Healthcare

Company image
Address

980 Great West Road, Brentford, Middlesex, TW8 9GS

Medical Information Direct Line

0800 783 8881

Customer Care direct line

0800 783 8881

Telephone

+44 (0)20 8047 5000

Medical Information e-mail
Medical Information Fax

+44 (0)20 8047 6860

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

light liquid paraffin, white soft paraffin

Legal categories

GSL - General Sales List

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