ZACIN Cream Ref.[49894] Active ingredients: Capsaicin

Absorption after topical application is unknown. Average consumption of dietary spice from capsicum fruit has been estimated at 2.5 g/person/day in India and 5.0 g/person/day in Thailand. Capsaicin content in capsicum fruit is approximately 1% therefore dietary intake of capsaicin may range from 0.5-1 mg/kg/day for a 50 kg person. Application of two tubes of Zacin Cream 0.025% (90 g) each week results in 3.21 mg/day topical exposure. Assuming 100% absorption in a 50 kg person, daily exposure would be 0.064 mg/kg which is approximately one seventh to one eighth of the above mentioned dietary intake.

The available animal toxicity data relating to capsicum, capsicum extracts and capsaicin do not suggest that, in usual doses, they pose any significant toxicity hazard to man. Thus, in both single and repeat dosing studies which have been reported, capsicum extracts and capsicum are generally well-tolerated at many times even the highest estimated human intakes. The safety of Zacin for use in human pregnancy has not been established since no formal reproduction studies have been performed in either animals or man. However, there is no reason to suspect from human or animal studies currently available that any adverse effects in humans are likely.

Studies reported in the published literature which relate to potential genotoxic and carcinogenic action of capsaicin have produced inconclusive and conflicting data. However, it is unlikely that capsaicin, in the quantities absorbed transdermally from Zacin cream, will pose any significant hazard to humans.