Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 41e2dbb1-4f7e-4d7e-8998-242029ebe52a
Route
ORAL
Published
Effective Date 2013-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Benzyl Alcohol D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Methylparaben Polyethylene Glycol 400 Propylene Glycol Saccharin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2008-08-01
Description

Benzocaine, 20%

Purpose

Oral anesthetic

Medication Information

Purpose

Oral anesthetic

Description

Benzocaine, 20%

Uses

Provides temporary relief of pain associated with the following mouth and gum irritations:

  • toothache
  • sore gums
  • canker sores
  • braces
  • minor dental procedures
  • dentures
Section 42229-5

Section 51945-4

purpose

Oral anesthetic

warnings

Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

directions
  • Adults and children 2 years of age and older:
  • wipe liquid on with cotton, or cotton swab, or finger tip.
  • apply to the affected area up to 4 times daily of as directed by a doctor or dentist.
  • Children under 12 years of age: adult supervision should be given in the use of this product.
  • Children under 2 years of age: consult a doctor or dentist.
Active Ingredient

Benzocaine, 20%

inactive Ingredients

Benzyl alcohol, FD&C Blue #1, FD&C Red #40, D&C yellow #10, Flavor, Methylparaben, Polyethylene Glycol, Propylene Glycol, Saccharin

when Using This Product
  • avoid contact with eyes
  • do not exceed recommended dosage
  • do not use for more than 7 days unless directed by a doctor or dentist
keep Out of Reach of Children
  • If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away
stop Use and Ask A Doctor Or Dentist If
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops

Structured Label Content

Uses

Provides temporary relief of pain associated with the following mouth and gum irritations:

  • toothache
  • sore gums
  • canker sores
  • braces
  • minor dental procedures
  • dentures
Section 42229-5 (42229-5)

Section 51945-4 (51945-4)

purpose (Purpose)

Oral anesthetic

warnings (Warnings)

Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

directions (Directions)
  • Adults and children 2 years of age and older:
  • wipe liquid on with cotton, or cotton swab, or finger tip.
  • apply to the affected area up to 4 times daily of as directed by a doctor or dentist.
  • Children under 12 years of age: adult supervision should be given in the use of this product.
  • Children under 2 years of age: consult a doctor or dentist.
Active Ingredient (Active ingredient)

Benzocaine, 20%

inactive Ingredients (Inactive ingredients)

Benzyl alcohol, FD&C Blue #1, FD&C Red #40, D&C yellow #10, Flavor, Methylparaben, Polyethylene Glycol, Propylene Glycol, Saccharin

when Using This Product (When using this product)
  • avoid contact with eyes
  • do not exceed recommended dosage
  • do not use for more than 7 days unless directed by a doctor or dentist
keep Out of Reach of Children (Keep out of reach of children)
  • If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away
stop Use and Ask A Doctor Or Dentist If (Stop use and ask a doctor or dentist if)
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:39.271352 · Updated: 2026-03-14T22:53:30.775793