Spotoway Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Spotoway Cream.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate BP 1.00% w/w.
3 PHARMACEUTICAL FORM
Cream for external use.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the topical treatment of acne (spots and pimples etc.).
4.2 Posology and method of administration
Adults (including the elderly) and children - Topical application to lesions and surrounding skin three to four times a day.
4.3 Contraindications
Not applicable.
4.4 Special warnings and precautions for use
Not applicable.
4.5 Interaction with other medicinal products and other forms of interaction
Not applicable.
4.6 Pregnancy and lactation
Not applicable.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Not applicable.
4.9 Overdose
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Chlorhexidine Gluconate, Antiseptic for skin and mucous membrane. It has a rapid antibacterial action combined with strong binding to skin. Chlorhexidine has an extremely low level of toxicity.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
Water
6.1 List of excipients
Cetostearyl Alcohol*_
PEG-20 stearate*_
Mineral oil_
Extract of ( German Camomile, Sage, Milfoil, Witch Hazel, Rosemary, Rest
Harrow_
Horsetail and Marshmallow)**_
Methyl parahydroxybenzoate***_
Ethyl parahydroxybenzoate***_
Propyl parahydroxybenzoate***_
Butyl parahydroxybenzoate***_
Sodium benzoate**_
2-Bromo-2-nitropropane- 1,3-diol.**_
* Polawax
** Extrapone 4 Special *** Nipastat.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
24 Months.
6.4 Special precautions for storage
Usual - Avoidance of extremes of temperature.
6.5 Nature and contents of container
High density poly-propylene jar with matching lid. LLDPE plastic tube and cap.
30 g, 50g, 75g and 100g.
6.6 Special precautions for disposal
Topical application to lesions and surrounding skin. Three to Four Times a Day.
7 MARKETING AUTHORISATION HOLDER
Bee Health Ltd Carnaby Bridlington East Yorkshire YO15 3QY
8 MARKETING AUTHORISATION NUMBER(S)
PL 37056/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/02/1991 / 06/04/2005
10 DATE OF REVISION OF THE TEXT
15/06/2011