1. Name Of The Medicinal Product
Aqueous Cream B.P.
2. Qualitative And Quantitative Composition
|
|
|
|
3. Pharmaceutical Form
Cream
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of dry skin disorders.
For topical application to the skin.
4.2 Posology And Method Of Administration
Adults, children and elderly:
To be applied to the skin as required.
May also be used as a soap substitute.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
For external use only.
Keep all medicines out of the reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically significant drug interactions known.
4.6 Pregnancy And Lactation
The safety of aqueous cream during pregnancy and lactation has not been established but is not considered to constitute a hazard during these periods.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
Occasional hypersensitivity reactions.
4.9 Overdose
Symptoms of accidental oral ingestion may include gastrointestinal symptoms, particularly diarrhoea. Treatment need only be symptomatic.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
White soft paraffin and liquid paraffin have emollient properties.
5.2 Pharmacokinetic Properties
None applicable.
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Emulsifying wax
Chlorocresol
Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Tub: Store in a cool place.
Tube: None
6.5 Nature And Contents Of Container
Polypropylene jar with an unlined polypropylene cap.
Pack size 500g.
or Polypropylene securitub with a white pilfer-proof polythene cap.
Pack size: 500g
or Pigmented LDPE/HDPE tube fitted with a polypropylene screw cap.
Pack sizes: 60g, 100g
or Laminate tube fitted with a polypropylene screw cap.
Pack sizes: 60g, 100g
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
The Boots Company PLC
Nottingham
NG2 3AA
Trading as: BCM
8. Marketing Authorisation Number(S)
PL 00014/5202R
9. Date Of First Authorisation/Renewal Of The Authorisation
First Authorisation: 16 December 1986
Renewal: 16 December 1991
10. Date Of Revision Of The Text
June 2009
No comments:
Post a Comment