Cetanorm Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cetanorm Cream
Vantage Pharmacy Antiseptic Cream Savoy First Aid Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100g of cream contains the following active ingredients: Benzalkonium Chloride 0.10 G
Cetrimide 0.40 G
Chlorbutanol 0.10 G
Aldioxa 0.375 G
3 PHARMACEUTICAL FORM
Cream, for topical application.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
External treatment of cuts, scratches, abrasions, small wounds, and napkin rash.
4.2. Posology and Method of Administration
Apply sparingly two or three times per day ensuring the area is first free from soap.
No distinction is made between adults, children and the elderly.
4.3. Contra-Indications
Known sensitivity to any of the ingredients.
4.4. Special Warnings and Special Precautions For Use
Ensure the skin is washed free from soap before application.
4.5. Interaction with other Medicinal Products and other Forms of Interaction
Incompatible with soap and other anionic detergents.
4.6. Pregnancy and Lactation
The product is considered safe for use during pregnancy when used as directed, but medicaments should only be used at in pregnancy when anticipated benefits exceed the risks.
4.7. Effects on Ability to Drive and Use Machines
None
4.8. Undesirable Effects
Local irritation may occur.
4.9 Overdose
Overdose is unlikely when used as directed. If someone accidentally swallows this cream medical advice should be sought immediately.
5. Pharmacological Properties
5.1. Pharmacodynamic Properties
Allantoin and its derivatives stimulate tissue and accelerate wound healing. They appear to have a keratin dispersing activity.
The quaternary ammonium compounds have detergent, and gram positive and gram negative bactericidal activity.
Chlorbutol has antibacterial and antifungal activity. It also has a mild local anaesthetic action.
5.2. Pharmacokinetic Properties
When used as directed systemic absorption is negligible.
5.3. Pre-clinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1. List of Excipients
The cream also contains Cetyl Alcohol, Polychol 15, Wool Alcohols, Chlorhexidine Solution, Nonoxinol '9' and Deionised Water.
6.2. Incompatibilities
The product is not intended to be diluted before use.
6.3. Shelf Life
36 months in original container, 1 month after first opening
6.4. Special Precautions for Storage
Store between 4°C and 25°C.
6.5. Nature and Contents of Container
Collapsible Aluminium Tube containing 15g or 25g of product.
6.6. Instructions for Use, Handling and Disposal
None
7 MARKETING AUTHORISATION HOLDER
Norma Chemicals Ltd.
51-53 Stert Street Abingdon
Oxfordshire OX14 3JF United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 0386/5005R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
16 March 1990, 24 March 1996
10 DATE OF REVISION OF THE TEXT
20/04/2009