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Drugs and Health Products

Monograph: Male Genital Desensitizers

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. Notes: (i) Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. (ii) The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2013-01-22

NHPID Name

Benzocaine (O'Neil et al. 2012)

Proper Name(s)

4-Aminobenzoic acid, ethyl ester ( Merck 2012 )

Common Name(s)

Benzocaine ( Merck 2012 , CTFA 2008 , USP 35 )

Source Material

para-Aminobenzoic acid (Merck 2012, CTFA 2008)

Route Of Administration

Topical

Dosage Form(s)

Those pharmaceutical dosage forms suited to topical administration. Metered dose and chlorofluorcarbons (CFCs)-based aerosols/aerosol sprays and metered-dose pump sprays are unacceptable dosage forms.

Use(s) or Purpose(s)

Statement(s) to the effect of:

  • For reducing oversensitivity in advance of intercourse  (US FDA 1992)
  • For temporary male genital desensitisation, helping to slow the onset of ejaculation  (US FDA 1992)
  • Helps in temporarily retarding the onset of ejaculation/temporarily slowing the onset of ejaculation/temporarily prolonging the time until ejaculation  (US FDA 1992)
  • Helps in the prevention of premature ejaculation  (US FDA 1992)

Dose(s)

Adults:

Dose(s): 3 - 7.5 Percent , in a water-soluble base
Directions For Use:
  • Apply a small amount to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a health care practitioner (CPhA 1996, US FDA 1992)
  • Avoid contact with eyes. If this happens, immediately flush thoroughly with water.
  • For external use only.
  • Keep out of reach of children.
  • Use smallest amount possible to achieve desired result.
  • Wash product off after intercourse (CPhA 1996, US FDA 1992)
  • Wipe off any excess gel before commencing intercourse (CPhA 1996)

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a health care practitioner  (US FDA 1992)

Contraindication(s):
If the following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue coloured skin, stop use and consult a health care practitioner. These symptoms may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use  (HC 2011a, HC 2011b)

Known Adverse Reaction(s):
Hypersensitivity/allergy has been known to occur; in which case, discontinue use  (HC 2011a, HC 2011b, US FDA 1992)

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Storage Conditions

Aerosols/aerosol sprays and pump sprays: Store below 40C. (USP DI 2006) All products: Store in airtight container. Protect from light. (Martindale 2010) Semi-solid preparations (e.g. gels): Store between 15-30C. (USP DI 2006) Solutions: Store below 30C. (USP DI 2006)

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredients Database (NHPID). In addition, the medicinal ingredient may comply with the specifications outlined in the pharmacopoeial monographs: "Benzocaine" in the British Pharmacopoeia(BP), "Benzocaine" in the European Pharmacopoeia(Ph. Eur.) as well as "Benzocaine", "Benzocaine cream", "Benzocaine gel", "Benzocaine topical solution" and "Benzocaine topical aerosol" in the United States (USP) Pharmacopoeias.

References cited

  • BP 2012: British Pharmacopoeia 2012. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA); 2011.
  • CPhA 1996: Carruthers-Czyzewski P, Gillis C, Letwin D, editors. Nonprescription Drug Reference for Health Professionals. Ottawa (ON): Canadian Pharmaceutical Association; 1996.
  • CTFA 2008: Gottschalck TE, Bailey JE, editors. International Cosmetic Ingredient Dictionary and Handbook. 12th edition. Washington (DC): Cosmetic, Toiletry and Fragrance Association; 2008.
  • HC 2011a: Health Canada 2011. Health risks associated with the use of topical benzocaine products. Internal document. [Available on Request.]
  • HC 2011b : Health Canada reminds Canadians of health risks associated with topical benzocaine products. About Health Canada, Information update, Canada Vigilance Program, Marketed Health Products Directorate [Date modified : 2011-04-19; Accessed : 2012 July 10]. Available from: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_59-fra.php
  • Martindale 2010: Sweetman SC, editor. Martindale: The Complete Drug Reference. 37th edition [Internet]. London (GB): Pharmaceutical Press; 2010. [benzocaine: ethyl 4-aminobenzoate, CAS: 94-09-7, 20101127; Accessed 2012 July 30]. Available from: http://ovidsp.tx.ovid.com/
  • Merck 2012: O'Neil MJ, Heckelman PE, Koch CB, Roman KJ, editors. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals (14th Edition - Version 14.9). Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.; 2006, 2012. Available from: http://www.knovel.com/
  • Ph.Eur. 2012: European Pharmacopoeia. 7th edition. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM), 2012.
  • US FDA 1992: US Department of Health and Human Services, Food and Drug Administration. 21 CFR Part 348. [Docket No. 78N-0301]. Male Genital Desensitizing Drug Products for Over-the-Counter Human Use; Final Monograph. ACTION: Final Rule; DATES: This final rule is effective June 19, 1993 [Internet]. Federal Register, Volume 57, Number 119, June 19, 1993. [Accessed 2011 December 8]. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/UCM078147.pdf
  • USP 35: United States Pharmacopeia and the National Formulary (USP 35 - NF 30). Rockville (MD): The United States Pharmacopeial Convention; 2012.
  • USP DI 2006: Drug Information for the Health Care Professional. 26th edition, Volume 1. Greenwood Village (CO): Thomson Micromedex; 2006.

References reviewed

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