SPOTOWAY CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Spotoway Cream.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Chlorhexidine Gluconate BP 1.00% w/w.

Cream for external use.

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

6.1 List of excipients

Water

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.