Oral Pain Relief

Oral Pain Relief
SPL v2
SPL
SPL Set ID d294a39e-55f4-272d-e053-2995a90ab7f7
Route
ORAL
Published
Effective Date 2021-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Polyethylene Glycol 300 Polyethylene Glycol 400 Polyethylene Glycol 1500 Polyethylene Glycol 3350 Saccharin Sodium Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01
Description

Drug Facts

Purpose

Oral anesthetic

Medication Information

Purpose

Oral anesthetic

Description

Drug Facts

Uses

temporary relieves pain associated with the following mouth

and gum irritations: • toothache • sore gums • canker

sores • braces • minor dental procedures • dentures

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51945-4

Directions

• do not exceed recommended dosage

• do not use for more than 7 days unless told to do so by a dentist or doctor

• adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist

• children between 2 and 12 years of age: adult supervision should be given in use of this product

• children under 2 years of age: do not use

Do Not Use

• for teething

• in children under 2 years of age

• more than recommended

• for more than 7 days unless told to do so by a dentist or doctor

Active Ingredient

Benzocaine 20%

Other Information

• do not use tube if it is cut prior to opening

• to open tube, cut open tip of tube on score mark with scissors

• store at a controlled room temperature 68º-77ºF (20º-25ºC)

Inactive Ingredients

Flavor, PEG-6, PEG-8, PEG-32, PEG-75, Sodium Saccharin, Sorbic Acid

Questions Or Comments?

1-800-540-3765

When Using This Product

• avoid contact with the eyes

Stop Use and Ask A Doctor 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

temporary relieves pain associated with the following mouth

and gum irritations: • toothache • sore gums • canker

sores • braces • minor dental procedures • dentures

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Purpose

Oral anesthetic

Directions

• do not exceed recommended dosage

• do not use for more than 7 days unless told to do so by a dentist or doctor

• adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist

• children between 2 and 12 years of age: adult supervision should be given in use of this product

• children under 2 years of age: do not use

Do Not Use (Do not use)

• for teething

• in children under 2 years of age

• more than recommended

• for more than 7 days unless told to do so by a dentist or doctor

Active Ingredient

Benzocaine 20%

Other Information (Other information)

• do not use tube if it is cut prior to opening

• to open tube, cut open tip of tube on score mark with scissors

• store at a controlled room temperature 68º-77ºF (20º-25ºC)

Inactive Ingredients (Inactive ingredients)

Flavor, PEG-6, PEG-8, PEG-32, PEG-75, Sodium Saccharin, Sorbic Acid

Questions Or Comments? (Questions or Comments?)

1-800-540-3765

When Using This Product (When using this product)

• avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor 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: 2026-02-15T12:02:11.523572 · Updated: 2026-03-14T23:01:36.166619