- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
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.
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
4.6 Pregnancy and lactation
There are no restrictions on the use of Oilatum Junior Cream during pregnancy or lactation.
FertilityThere are no data on the use of topical Oilatum Junior Cream on human fertility
PregnancyThere 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.
LactationIt 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
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).
Skin and Subcutaneous Tissue DisordersRare: Application site reactions including application site erythema, rash, pain, pruritus, skin burning sensation.
Immune System DisordersRare: Application site hypersensitivity reactions including application site dermatitis.
Symptoms and signsThe 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.
TreatmentIn 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
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 sorbateBenzyl alcohol Citric acid monohydrate Povidone Purified water
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
7. Marketing authorisation holder
Beecham Group Plc trading as: Stiefel 980 Great West Road Brentford Middlesex TW8 9GSUnited 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
GlaxoSmithKline Consumer Healthcare
980 Great West Road, Brentford, Middlesex, TW8 9GS
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