AXSAIN Cream Ref.[49944] Active ingredients: Capsaicin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands

Product name and form

Axsain 0.075% w/w Cream.

Pharmaceutical Form

Cream.

A smooth, white cream.

Qualitative and quantitative composition

Capsaicin 0.075% w/w.

Excipient(s) with known effect:

Each cream tube contains;

  • 450 mg benzyl alcohol which is equivalent to 0.01 mg/mg
  • 3.6g cetyl alcohol which is equivalent to 0.08 mg/mg

For a 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 Parafin
Glyceryl stearate and PEG-100 stearate (Arlacel 165)
Benzyl Alcohol

Pack sizes and marketing

Aluminium tubes with epoxyphenolic lining and polypropylene cap, containing 45g of cream.

Marketing authorization holder

Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands

Marketing authorization dates and numbers

PA1986/088/001

Date of first authorisation: 14 June 1994
Date of last renewal: 14 June 2009

Drugs

Drug Countries
AXSAIN Ireland, United Kingdom

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