BENZAC(r) AC Wash Benzoyl Peroxide 50 mg/g
BENZAC AC Wash contains benzoyl peroxide 50mg/g in a gel base containing acrylates copolymer, glycerol, carbomer 940, sodium C14-C16 olefin sulfonate, sodium hydroxide and purified water.
Benzoyl peroxide has been shown to have potent broad spectrum antimicrobial activity, particularly against Proprionibacterium acnes which is normally present in affected hair follicles. In addition benzoyl peroxide has demonstrated exfoliative and comedolytic activities both of which are beneficial in the treatment of acne.
The percutaneous penetration of benzoyl peroxide in rat, rabbit, monkey and man is low. The majority of the penetrated benzoyl peroxide is converted into benzoic acid which after absorption into the systemic circulation is rapidly eliminated by the kidney. There is no evidence of any tissue accumulation. There is no evidence that cutaneous application of the proposed clinical doses of BENZAC AC Wash should be associated with any systemic adverse reactions in humans.
For the treatment of mild to moderate acne vulgaris.
Unless otherwise prescribed, the preparation should be applied twice daily to cover the affected skin. Wet the area to be treated. Apply the preparation to the hands and wash the affected areas with the solution. Contact time with the skin should be 30 seconds, followed by a thorough rinsing with water and drying.
BENZAC AC Wash is contraindicated in patients with a history of hypersensitivity to any of its ingredients.
For external use only. In normal use a mild burning sensation will probably be felt on first application and a moderate reddening and peeling of the skin will occur within a few days. During the first weeks of treatment a sudden increase in peeling will occur in most patients, this is not harmful and will normally subside within a day or two if treatment is temporarily discontinued. If severe irritation occurs, patients should be directed to use the medication less frequently, to temporarily discontinue use or to discontinue use altogether.
It is not known whether benzoyl peroxide is excreted in animal or human milk. Because many drugs are excreted in human milk, caution should be taken when BENZAC AC 5% Wash is administered to a nursing woman. In this event, the preparation should not be applied on the chest to avoid accidental transfer to the infant. BENZAC AC 5% Wash should not come into contact with eyes or mucous membranes. If the preparation enters the eye wash thoroughly with water. Caution should be exercised when applying BENZAC AC Wash to the neck and other sensitive areas. The repeated exposure to sunlight or UV irradiation should be avoided. Contact with any coloured material including hair and dyed fabrics may result in bleaching or discolouration.
The major adverse reaction reported to date with benzoyl peroxide cutaneous therapy is irritation of the skin at the site of application. This is reversed when treatment is reduced in frequency or discontinued.
There are no known interactions with other medications which might be used cutaneously and concurrently with BENZAC AC Wash however drugs with desquamative, irritant and drying effects should not be used concurrently with BENZAC AC Wash.
BENZAC AC Wash is for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and severe irritation might develop. In this event treatment must be discontinued and appropriate symptomatic therapy should be instituted.
Store below 25degC.
General Sale Medicine
200mL and 20ml
Nil.
| Galderma Australia Pty Ltd | Distributed in New Zealand by |
| 9 Rodborough Road, | Healthcare Logistics |
| Frenchs Forest, NSW 2086 | 58 Richard Pearse Drive |
| Airport Oaks | |
| Auckland | |
| New Zealand | |
| Ph (09) 918 5100 | |
| Fax (09) 918 5101 | |
1 May 2006