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BOOTS SKIN THERAPY EMOLLIENT CREAM

Active substance(s): ALMOND OIL / ANHYDROUS LANOLIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Skin Therapy Emollient Cream or Boots Derma Care Emollient Cream

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient Almond Oil BP '88 Anhydrous Lanolin EP w/w 5% 1%

3.

PHARMACEUTICAL FORM Cream

4.
4.1

Clinical Particulars
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

Contra-Indications Hypersensitivity to any of the ingredients.

4.4

Special Warnings and Special Precautions for Use Not applicable.

4.5 Interactions 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
5.1

PHARMACOLOGICAL PROPERTIES
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
6.1

PHARMACEUTICAL PARTICULARS
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 None.

7.

MARKETING AUTHORISATION HOLDER The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

8.

MARKETING AUTHORISATION NUMBER PL 00014/0369.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION First authorisation: Last renewal: 19 May 1988 15 September 1993

10

DATE OF REVISION OF THE TEXT
08/12/2010

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