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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.



August 5, 2019

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s) Common name(s) Source information
Source ingredient(s)

4-Aminobenzoic acid, ethyl ester



References: Proper name: Merck 2012; Common name: Merck 2012, USP 35 2012, CTFA 2008; Source information: Merck 2012, CTFA 2008.

Route of Administration


Dosage Form(s)

Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

The following combined use(s) or purpose(s) is/are also acceptable:

For temporary male genital desensitisation to reduce oversensitivity in advance of intercourse and help slow the onset of ejaculation (US FDA 1992).



Adults 18 years and older


3 - 7.5% of Benzocaine (US FDA 1992)

Note: Should be prepared in a water-soluble base

Direction(s) for use

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)


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

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (HC 2011a,b; US FDA 1992).

Non-medicinal ingredients

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

Storage conditions

All products

Store in airtight container protected from light (Martindale 2010).

Aerosols/aerosol sprays and pump sprays

Store below 40°C (USP DI 2006).

Semi-solid preparations (e.g. gels)

Store between 15-30°C (USP DI 2006).


Store below 30°C (USP DI 2006).


References Cited

References Reviewed