BOOTS COMPANY PLC

1 Thane Road West, Beeston, Nottingham, NG2 3AA
Telephone: +44 (0)1159 595 306
Fax: +44 (0)1159 592 565


Summary of Product Characteristics last updated on the eMC: 04/05/2011
SPC Boots Derma Care Emollient Cream


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1. NAME OF THE MEDICINAL PRODUCT

Boots Derma Care Emollient Cream


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient

w/w

Almond Oil BP'88

5%

Anhydrous Lanolin HSE

1%


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3. PHARMACEUTICAL FORM

Cream


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4. CLINICAL PARTICULARS

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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.


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4.2 Posology and method of administration

Adults, children and the elderly

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


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4.3 Contraindications

Hypersensitivity to any of the ingredients.


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4.4 Special warnings and precautions for use

Not applicable


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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4.6 Pregnancy and lactation

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


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4.7 Effects on ability to drive and use machines

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


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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.


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4.9 Overdose

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


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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


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5.2 Pharmacokinetic properties

None stated.


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5.3 Preclinical safety data

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


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

White soft paraffin

Cetomacrogol 1000

Arlacel 83

Cetyl alcohol

Benzyl alcohol

Citric acid anhydrous

Sodium citrate

Purified water


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6.2 Incompatibilities

None.


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6.3 Shelf life

36 months.


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6.4 Special precautions for storage

None.


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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


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6.6 Special precautions for disposal and other handling

None.


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7. MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA


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8. MARKETING AUTHORISATION NUMBER(S)

PL00014/0369.


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

First authorisation: 19 May 1988

Last renewal: 15 September 1993


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10. DATE OF REVISION OF THE TEXT

September 2010



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/11910/SPC/


Active Ingredients/Generics

 
   lanolin, anhydrous
   almond oil