ZACIN Cream Ref.[49894] Active ingredients: Capsaicin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Cephalon UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom

Product name and form

Zacin 0.025% w/w Cream.

Pharmaceutical Form

Cream for topical application.

Qualitative and quantitative composition

Capsaicin 0.025% w/w.

Excipient(s) with known effect:

Each cream tube contains 450 mg benzyl alcohol which is equivalent to 0.01 mg/mg.

Each cream tube contains 3.6g Cetyl alcohol which is equivalent to 0.08 mg/mg

For the full list of excipients, see section 6.1.

Active Ingredient Description
Capsaicin

Capsaicin, or 6-nonenamide, N-[(4-hydroxy-3-methoxyphenyl) methyl]-8-methyl, (6E), is a highly selective agonist for the transient receptor potential vanilloid 1 receptor (TRPV1). The initial effect of capsaicin is the activation of TRPV1-expressing cutaneous nociceptors, which results in pungency and erythema due to the release of vasoactive neuropeptides.

List of Excipients

Purified water
Sorbitol solution
Isopropyl myristate
Cetyl alcohol
White soft paraffin
Glyceryl stearate and Peg-100
Stearate (Arlacel 165)
Benzyl alcohol

Pack sizes and marketing

Aluminium tubes with epoxyphenolic lining and polypropylene spiked cap containing 45 g of Zacin Cream 0.025%.

Marketing authorization holder

Cephalon UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom

Marketing authorization dates and numbers

PL 16260/0028

22 March 2010

Drugs

Drug Countries
ZACIN Ireland, United Kingdom

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