Boots Skin Therapy Emollient Cream

1. Name Of The Medicinal Product

Boots Derma Care Emollient Cream

2. Qualitative And Quantitative Composition

Active Ingredient	w/w
Almond Oil BP'88	5%
Anhydrous Lanolin HSE	1%

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of dry skin conditions such as chapping caused by weather or water, nappy soreness, dry eczema and sunburn.

For topical application.

4.2 Posology And Method Of Administration

Adults, children and the elderly

Apply to the affected area two or three times a day.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Not applicable

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions are required in pregnancy and breast feeding mothers.

4.7 Effects On Ability To Drive And Use Machines

This product has no effect on the ability to drive or operate machinery.

4.8 Undesirable Effects

Adverse reactions are unlikely, but may cause an allergic skin reaction, in which case use of the product should be discontinued.

4.9 Overdose

This product has low toxicity. If accidental ingestion occurs, conservative treatment only is required.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Lanolin and almond oil help to moisturise the skin and prevent soreness.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. Pharmaceutical Particulars

6.1 List Of Excipients

White soft paraffin

Cetomacrogol 1000

Arlacel 83

Cetyl alcohol

Benzyl alcohol

Citric acid anhydrous

Sodium citrate

Purified water

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Lacquered collapsible aluminium tube with a polypropylene or polythene screw cap.

Pack sizes: 50g, 60g

A polypropylene securitainer with a polythene pilfer-proof screw cap.

Pack size: 300g, 325g, 350g

Polypropylene pump dispenser with polyethylene plunger

Pack size: 100ml

Pump pack consisting of a polypropylene jar and a polyethylene, polypropylene pump dispenser.

Pack sizes: 300g, 500g

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL00014/0369.

9. Date Of First Authorisation/Renewal Of The Authorisation

First authorisation: 19 May 1988

Last renewal: 15 September 1993

10. Date Of Revision Of The Text

September 2010