What is it used for?
Buccal/Oromucosal
For the temporary relief of occasional minor oral irritation/oral pain/sore mouth [Source note 2].
For the temporary relief of pain associated with canker sores/aphthous stomatitis [Source note 3]
For the temporary relief of pain associated with cold sores/fever blisters/oral herpes [Source note 4].
For the temporary relief of occasional minor irritation or injury of the mouth [Source note 5].
For the temporary relief of pain due to minor irritation of the mouth due to dentures or orthodontic appliances [Source note 6].
Dental For the temporary relief of pain arising as a result of toothache [Source note 7].
Oral
For temporary relief of (pain of) (minor) sore throat [Source note 8].
Temporarily relieves/soothes (pain of) (minor) sore throat.
Periodontal/Gingival
For the temporary relief of occasional minor irritation or injury of the gums [Source note 9].
For the temporary relief of pain due to minor dental procedures [Source note 10].
For the temporary relief of pain due to minor irritation of the gums due to dentures or orthodontic appliances [Source note 11].
Topical
For the temporary relief of pain associated with cold sores/fever blisters/oral herpes [Source note 12].
Note: The above uses can be combined on the product label (e.g., For the temporary relief of pain associated with canker sores and cold sores).
Who does this guide cover?
Gingival paste; Film-forming gel; Gargle; Lozenge; Mouthwash
Children 6 to 11 years, Adolescents 12 to 17 years, Adults 18 years and older
Aerosol, spray; Cream; Gel; Gingival gel; Liquid; Ointment; Solution; Spray
Children 2 to 11 years, Adolescents 12 to 17 years, Adults 18 years and older
How is it taken?
Buccal
Dental
Gingival
Oral
Oromucosal
Periodontal
Topical
Which forms are covered?
this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.
The following dosage forms are acceptable when used according to the requirements indicated in this reference: 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.
Quantities
Lozenge
2 - 15 milligrams of Benzocaine, per single dose; up to 6 times, per day [Source note 13]
Aerosol, spray; Cream; Film-forming gel; Gargle; Gel; Gingival gel; Gingival paste; Liquid; Mouthwash; Ointment; Solution; Spray
5 - 20% of Benzocaine [Source note 14]
How is it used?
All products
Use the smallest amount possible to achieve desired result.
Children under 12 years of age should be supervised by an adult in the use of this product [Source note 15].
Products for relief of sore throat
Gargle
Gargle for at least 1 minute and then spit out.
Use up to 4 times per day (or as directed by a dentist/healthcare professional) [Source note 16].
Lozenge
Allow product to dissolve slowly in the mouth.
Do not bite, chew or swallow whole.
May be repeated every 2 hours as needed (or as directed by a dentist/healthcare professional) [Source note 17].
Aerosol, spray; Spray
Spray on the affected area(s) for 1 second or less, up to 4 times per day [Source note 18].
Avoid inhaling [Source note 19].
Use only when specifically directed by a dentist/healthcare professional [Source note 20].
Products for relief of dental appliance pain
Cream; Gel; Gingival gel; Liquid; Ointment; Solution
Apply to the affected area(s), wait until relief is obtained, and rinse the mouth before reinserting the appliance [Source note 21].
When using this product to relieve pain during adjustment of new dentures or other dental appliances, contact a dentist at regular intervals [Source note 22].
All products except for products for the relief of dental appliance pain and sore throat
Aerosol, spray; Spray
Spray on the affected area(s) for 1 second or less, up to 4 times per day [Source note 23].
Avoid inhaling [Source note 24].
Use only when specifically directed by a dentist/healthcare professional [Source note 25].
Cream; Gel; Gingival gel; Liquid; Ointment; Solution
Apply to the affected area(s) up to 4 times per day with cotton, cotton applicator/swab or a fingertip (or as directed by a dentist/healthcare professional) [Source note 26].
Gingival paste
Dab small amounts up to 4 times per day onto the affected area with cotton applicator/swab (or as directed by a dentist/healthcare professional) [Source note 27].
Avoid rubbing or spreading, to prevent crumbling or grittiness [Source note 28].
Film-Forming gels
Dry the affected area(s) with one of the swabs provided [Source note 29].
Apply gel to a second swab and roll over the affected area(s) [Source note 30].
Keep mouth open and dry for 30 to 60 seconds after applying while film forms [Source note 31].
Do not remove film which will slowly disintegrate over 6 hours [Source note 32].
Apply up to 4 times per day (or as directed by a dentist/healthcare professional) [Source note 33].
Mouthwash
Swish around in the mouth, or allow to remain in place for at least 1 minute and then spit out.
Use up to 4 times per day (or as directed by a dentist/healthcare professional) [Source note 34].
How long is it used?
All products
For occasional use only.
Warnings and precautions
All products
Keep out of reach of children. In case of overdose, call a poison control centre or get medical help right away.
When using this product do not chew gum or food while numbness persists [Source note 35].
All products except for lozenge
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
All products except topical products and products for relief of sore throat
Ask a dentist/healthcare professional immediately if symptoms do not improve within 7 days, irritation, pain or redness persists or worsens, or swelling, rash or fever develops [Source note 36].
Products for relief of sore throat
Stop use and ask a healthcare professional if sore throat is severe, persists for more than 2 days, or is accompanied by or followed by other symptoms such as fever, headache, rash, swelling, nausea, or vomiting [Source note 37].
When should it be avoided?
All products
Do not use if you are allergic to benzocaine [Source note 38].
Possible side effects
All products
Stop use and ask a healthcare professional 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 (US FDA 2018; US FDA 2011a,b; HC 2006).
Stop use if hypersensitivity/allergy occurs [Source note 39].
Storage
Must be established in accordance with the requirements described in the applicable product regulations.
Preparation details
Ingredient identity, preparation requirements, and other details that define the scope of this guide.
Ingredients and preparations
| Proper name(s) | Common name(s) | Source information / Source ingredient(s) |
|---|---|---|
| 4-Aminobenzoic acid, ethyl ester | Benzocaine | Benzocaine |
References: Proper name: RSC 2025; Common name: RSC 2025; USP-NF 2024; CTFA 2008; Source information: RSC 2025; CTFA 2008.
Other ingredients
Must be chosen from the current source ingredient database and must meet the limitations outlined in the database.
Preparation and quality requirements
The finished product specifications must be established in accordance with the requirements described in the source authority source’s product quality guidance.
The active ingredient must comply with the requirements outlined in the source ingredient database.
Guide change history
Updates to this SupplementSafety.org guide.
Minor updates
Updated guide wording, organization, and source presentation. Added our editorial change history.
Initial release
Initial SupplementSafety.org guide prepared from source reference material.
Validation: Not yet completed. Editorial updates do not constitute clinical validation.
Sources
Source information
This guide organizes source material about uses, preparations, amounts, and precautions. Read the conditions alongside each statement; the information may apply only to particular preparations or populations.
The source document includes supporting references. We have not independently summarized or assessed every cited study for this guide.
- Source document version
- July 31, 2026
- Source captured
- Aug 15, 2026
- Editorial work
- Editorial preparation. Independent clinical review has not been recorded for this guide.
Full citations are available through the link above. Verification is required to open them; reading this guide does not require verification.
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