Benzocaine

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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 ingredients.

Notes

Date

March 19, 2021

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

Benzocaine

Benzocaine

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

Route(s) of administration

Dosage form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

The following dosage forms are acceptable when used according to the requirements indicated in this monograph: Aerosol, spray; Cream; Film-forming gel; Gargle; Gel; Gingival gel; Gingival paste; Liquid; Lozenge (oral only); Mouthwash; Ointment; Solution; Spray.

Note

Dosage forms must be acceptable for the specified route of administration.

Use(s) or Purpose(s)

Buccal/Oromucosal Dental

For the temporary relief of pain arising as a result of toothache (US FDA 1991).

Oral

For the temporary relief of (pain of) sore throat (US FDA 1991).

Periodontal/Gingival Topical

For the temporary relief of pain associated with cold sores/fever blisters/oral herpes (USP DI 2006; CPhA 1996).

Dose(s)

Subpopulation(s)

Gingival paste; Film-forming gel; Gargle; Lozenge; Mouthwash

Children, Adolescents and Adults 6 years and older

Aerosol, spray; Cream; Gel; Gingival gel; Liquid; Ointment; Solution; Spray

Children, Adolescents and Adults 2 years and older

Quantity(ies)

Lozenge

2 - 15 milligrams of Benzocaine, per single dose; 1 to 6 times, per day (USP DI 2006; US FDA 1991)

Aerosol, spray; Cream; Film-forming gel; Gargle; Gel; Gingival gel; Gingival paste; Liquid; Mouthwash; Ointment; Solution; Spray

5 - 20% of Benzocaine (US FDA 1991)

Directions for use

All products

All products except for lozenge

Avoid contact with eyes. Immediately flush thoroughly with water if contact occurs.

Products for relief of sore throat

Gargle

Lozenge

Aerosol, spray; Spray

Products for relief of dental appliance pain

Cream; Gel; Gingival gel; Liquid; Ointment; Solution

All products except for products for the relief of dental appliance pain and sore throat

Aerosol, spray; Spray

Cream; Gel; Gingival gel; Liquid; Ointment; Solution

Apply to the affected area up to four times daily with cotton, cotton applicator/swab or a fingertip or as directed by a dentist or another health care practitioner/health care provider/health care professional/doctor/physician (USP DI 2006).

Gingival paste

Dab small amounts as needed onto the affected area with cotton applicator/swab, avoiding rubbing or spreading, to prevent crumbling or grittiness (USP DI 2006)

Film-Forming gels

  1. Dry the affected area with one of the swabs provided (USP DI 2006).
  2. Apply gel to a second swab and roll over the affected area (USP DI 2006).
  3. Keep mouth open and dry for 30 to 60 seconds after applying while film forms (USP DI 2006).
  4. Do not remove film which will slowly disintegrate over six hours (USP DI 2006).
  5. Apply up to four times a day or as directed by a dentist or another health care practitioner/health care provider/health care professional/doctor/physician (USP DI 2006).

Mouthwash

Duration(s) of use

All products

For occasional use only.

Risk information

Caution(s) and warning(s)

All products

Keep out of reach of children.

All products except topical products and products for relief of sore throat

Consult your dentist or another health care practitioner/health care provider/health care professional/doctor/physician promptly if symptoms do not improve within seven days, irritation, pain or redness persists or worsens, or swelling, rash or fever develops (USP DI 2006; US FDA 1991).

Products for relief of sore throat

Consult a health care practitioner/health care provider/health care professional/doctor/physician promptly if sore throat is severe, persists for more than two days, or is accompanied by or followed by other symptoms such as fever, headache, rash, swelling, nausea, or vomiting (Pray 2006; USP DI 2006; US FDA 1991).

Contraindication(s)

All products

Known adverse reaction(s)

All products

Stop use if hypersensitivity/allergy occurs (HC 2011a;b US FDA 1991).

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

Specifications

References cited

References reviewed