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. Clinical Particulars
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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None.
4.6 Pregnancy And Lactation
There is no or inadequate evidence of the safety of Oilatum Shower Gel Fragrance-Free in human pregnancy and lactation. Topical preparations containing light liquid paraffin have been in wide use for many years without apparent ill consequence.
4.7 Effects On Ability To Drive And Use Machines
None.
4.8 Undesirable Effects
None
4.9 Overdose
Not applicable.
5. Pharmacological Properties
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. Pharmaceutical Particulars
6.1 List Of Excipients
Polyethylene 617A
2-octadodecanol
Polyethylene glycol 400 dilaurate.
Polyoxyethylene 40 sorbital septaoleate
Polyethylene glycol-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 screw cap. Capacity 25 g, 30 g, 125 g 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
GlaxoSmithKline UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
Trading as Stiefel
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
8. Marketing Authorisation Number(S)
PL 19494/0065
9. Date Of First Authorisation/Renewal Of The Authorisation
24th June 1993
10. Date Of Revision Of The Text
15 December 2010
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