- Approval Id
- daea454d1f8c4904
- Drug Approval Emc Name
- Oilatum Junior Cream (tube)
- Drug Name
- Oilatum Junior Cream (tube)
- Company Address
- Linthwaite, Huddersfield, West Yorks, HD7 5QH
- Company Website
- http://www.thorntonandross.co.uk
- Company Medical Info Direct Line
- +44 (0) 1484 848164
- Company Medical Info Email
- thorntonross@medinformation.co.uk
- Company Customer Care Direct Line
- +44(0)1484 848200
- Legal Category
- General Sales List
- Authorisation Holder
- Thornton & Ross Ltd.
Linthwaite,
Huddersfield,
HD7 5QH, UK
- Authorisation Number
- PL 00240/0467
- Authorisation Date
- 07/12/2010
- Instruction Authorisation Holder
- Thornton & Ross Ltd.
Linthwaite,
Huddersfield,
HD7 5QH, UK
- Instruction Authorisation Number
- PL 00240/0467
- Instruction Authorisation Date
- 07/12/2010
- Instruction Composition
- Contains Light Liquid Paraffin 6.0% w/w and White Soft Paraffin 15.0% w/w in a cream base.
Excipient(s) with known effect
Benzyl Alcohol 0.5%w/w
Cetostearyl alcohol
Potassium Sorbate
For the full list of excipients, see Section 6.1.
- Instruction Dosage Form
- Cream.
A white to off-white cream.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Oilatum 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 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 Cream is suitable for adults, children and the elderly.4.3 Contraindications
Should not be used in patients with known hypersensitivity to any of the ingredients.4.4 Special warnings and precautions for use
Oilatum 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).
This medicine contains 0.5% w/w benzyl alcohol which may cause allergic reactions and mild local irritation.
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.4.5 Interaction with other medicinal products and other forms of interaction
None.4.6 Fertility, pregnancy and lactation
\*\*Fertility\*\*
There are no data on the use of topical Oilatum Cream on human fertility
\*\*Pregnancy\*\*
There are no data on the use of topical Oilatum 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 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.
\*\*\*\*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.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.
- Instruction Pharmacology
- 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.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Macrogol 1000 Monostearate
Cetostearyl alcohol
Glycerol
Potassium sorbate
Benzyl alcohol (0.5%w/w)
Citric acid monohydrate
Povidone
Purified water6.2 Incompatibilities
None.6.3 Shelf life
Three years.6.4 Special precautions for storage
Store below 25 ○ C6.5 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 & 150g in a high density polyethylene tube.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
None.
- Instruction Content
- ## Composition
Contains Light Liquid Paraffin 6.0% w/w and White Soft Paraffin 15.0% w/w in a cream base.
Excipient(s) with known effect
Benzyl Alcohol 0.5%w/w
Cetostearyl alcohol
Potassium Sorbate
For the full list of excipients, see Section 6.1.
## Pharmaceutical Form
Cream.
A white to off-white cream.
## Clinical Particulars
4.1 Therapeutic indications
Oilatum 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 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 Cream is suitable for adults, children and the elderly.4.3 Contraindications
Should not be used in patients with known hypersensitivity to any of the ingredients.4.4 Special warnings and precautions for use
Oilatum 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).
This medicine contains 0.5% w/w benzyl alcohol which may cause allergic reactions and mild local irritation.
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.4.5 Interaction with other medicinal products and other forms of interaction
None.4.6 Fertility, pregnancy and lactation
\*\*Fertility\*\*
There are no data on the use of topical Oilatum Cream on human fertility
\*\*Pregnancy\*\*
There are no data on the use of topical Oilatum 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 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.
\*\*\*\*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.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.
## 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.
## Pharmaceutical Particulars
6.1 List of excipients
Macrogol 1000 Monostearate
Cetostearyl alcohol
Glycerol
Potassium sorbate
Benzyl alcohol (0.5%w/w)
Citric acid monohydrate
Povidone
Purified water6.2 Incompatibilities
None.6.3 Shelf life
Three years.6.4 Special precautions for storage
Store below 25 ○ C6.5 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 & 150g in a high density polyethylene tube.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
None.
- Company Detail Path
- /organization/thornton-and-ross-ltd
