Aqueous Cream BP (Thornton & Ross Ltd)

1. Name Of The Medicinal Product

Aqueous Cream BP

2. Qualitative And Quantitative Composition

No active ingredient.

3. Pharmaceutical Form

Cream.

4. Clinical Particulars

4.1 Therapeutic Indications

1. For relief of the symptoms of dry or chapped skin.

2. For use as a vehicle.

4.2 Posology And Method Of Administration

Topical: Apply to the affected part as required.

4.3 Contraindications

Contra-indicated in patients with know hypersensitivity to phenoxyethanol.

4.4 Special Warnings And Precautions For Use

For external use only.

Keep all medicines away from children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

The product is unlikely to have any adverse effects when used as indicated.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

An overdose is not considered likely when used as indicated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Aqueous cream acts to hydrate the skin, and aids the penetration of active drug in the preparations in which it is used.

It is used to re-hydrate dry or chapped skin.

5.2 Pharmacokinetic Properties

No information available.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Emulsifying wax BP, white petroleum jelly BP, liquid paraffin BP, phenoxyethanol BP and purified water BP.

6.2 Incompatibilities

No major incompatibilities are known.

6.3 Shelf Life

50g, 100g, 120g:	36 months unopened
100ml:	18 months unopened
500g:	36 months unopened

6.4 Special Precautions For Storage

Store below 25°C. Keep well closed. Do not allow to freeze.

6.5 Nature And Contents Of Container

50g, 100g, 120g	White polyethylene/Aluminium/co-polymer laminated plastic tube, with polypropylene cap.
100ml:	Polypropylene jar and lid.
500g:	Polypropylene jar and lid.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Thornton & Ross Ltd., Huddersfield, HD7 5QH, England.

8. Marketing Authorisation Number(S)

PL 00240/6274R

9. Date Of First Authorisation/Renewal Of The Authorisation

25.3.87

10. Date Of Revision Of The Text

14.05.09

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable