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- Oilatum Shower Gel Fragrance-Free
Oilatum
Summary of product characteristics
1. Name of the medicinal product
Oilatum Shower Gel Fragrance-Free
2. Qualitative and quantitative composition
Light liquid paraffin 70.0% w/w
3. Pharmaceutical form
Gel for topical use
4.1. Therapeutic indications
Oilatum Shower Gel Fragrance-Free is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritis, ichthyosis and related dry skin conditions.
4.2. Posology and method of administration
Adults, children and the elderly:
Oilatum Shower Gel Fragrance-Free may be used as frequently as necessary. Oilatum Shower Gel Fragrance-Free should always be applied to wet skin, normally as a shower gel.
Shower as usual. Apply Oilatum Shower Gel Fragrance-Free liberally to wet skin and massage gently. Rinse briefly and lightly pat the skin dry.
4.3. Contraindications
None.
4.4. Special warnings and precautions for use
Oilatum Shower Gel Fragrance-Free should not be used on greasy skin. Use care to avoid slipping in the shower.
Oilatum Shower Gel Fragrance-Free 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.
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 Oilatum Shower Gel Fragrance-Free on human fertility.
Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to Oilatum Shower Gel Fragrance-Free is expected to be low.
Lactation
It is not known if Oilatum Shower Gel Fragrance-Free 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
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.
4.9. Overdose
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.
5.1. Pharmacodynamic properties
Light liquid paraffin exerts an emollient effect by forming an occlusive oil film in the stratum corneum. This prevents excessive evaporation of water from the skin surface thus improving hydration.
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Not applicable. The relevant information is given in Section 4 of the Summary of Product Characteristics
6.1. List of excipients
Polyethylene
2-octadodecanol
Polyethylene glycol 400 dilaurate.
Polyoxyethylene 40 sorbitol septaoleate
Polypropyleneglycol-2-myristyl ether propionate
Polyphenylmethyl siloxane copolymer
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
For the product as packaged for sale
3 years
6.4. Special precautions for storage
Store below 25 °C.
6.5. Nature and contents of container
High density polyethylene tube fitted with a polypropylene screw cap. Capacity 25 g, 30 g, 125 g and 150g.
Polyethylene/ethylene vinyl alchol co-polymer (EVOH)/polyethylene laminate with a polyethylene shoulder, membrane seal, and a polypropylene cap. Capacity 30g and 150g.
6.6. Special precautions for disposal and other handling
There are no special instructions for use or handling of Oilatum Shower Gel Fragrance-Free.
7. Marketing authorisation holder
Thornton & Ross Ltd.
Linthwaite,
Huddersfield,
HD7 5QH, UK
8. Marketing authorisation number(s)
PL 00240/0465
9. Date of first authorisation/renewal of the authorisation
24 June 1993
10. Date of revision of the text
15/10/2019
4.1 Therapeutic indications
Oilatum Shower Gel Fragrance-Free is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritis, ichthyosis and related dry skin conditions.
4.2 Posology and method of administration
Adults, children and the elderly:
Oilatum Shower Gel Fragrance-Free may be used as frequently as necessary. Oilatum Shower Gel Fragrance-Free should always be applied to wet skin, normally as a shower gel.
Shower as usual. Apply Oilatum Shower Gel Fragrance-Free liberally to wet skin and massage gently. Rinse briefly and lightly pat the skin dry.
4.3 Contraindications
None.
4.4 Special warnings and precautions for use
Oilatum Shower Gel Fragrance-Free should not be used on greasy skin. Use care to avoid slipping in the shower.
Oilatum Shower Gel Fragrance-Free 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.
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 Oilatum Shower Gel Fragrance-Free on human fertility.
Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to Oilatum Shower Gel Fragrance-Free is expected to be low.
Lactation
It is not known if Oilatum Shower Gel Fragrance-Free 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
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.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
Disclaimer
The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.
Medthority will not be held liable for explicit or implicit errors, or missing data.
Drug Licencing
Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).