Oral Pain Relief Gel

Oral Pain Relief Gel
SPL v1
SPL
SPL Set ID 43af5b3f-4cda-4317-8c83-ff8d35786cb5
Route
TOPICAL
Published
Effective Date 2022-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-03-25
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For oral use only.

Indications and Usage

Uses

For the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

Dosage and Administration

Directions

Adults and children (2 years and older):

Dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If accidentally swallowed get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a dentist or doctor if

  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, fever or other allergic reaction develops
Section 50570-1

stop use and ask a doctor if get any discomfort.

Section 51727-6

Inactive ingredients

Polyethylene Glycol, Fragrance

Section 51945-4

Benzocaine 20% | Oral Anesthetic

NET WT 0.75 g

Section 55105-1

Purpose

Oral anesthetic

Section 55106-9

Active ingredient

Benzocaine 20% (w/w)

Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

Dosage and Administration (34068-7)

Directions

Adults and children (2 years and older):

Dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.

Warnings and Precautions (34071-1)

Warnings

For oral use only.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If accidentally swallowed get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a dentist or doctor if

  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, fever or other allergic reaction develops
Section 50570-1 (50570-1)

stop use and ask a doctor if get any discomfort.

Section 51727-6 (51727-6)

Inactive ingredients

Polyethylene Glycol, Fragrance

Section 51945-4 (51945-4)

Benzocaine 20% | Oral Anesthetic

NET WT 0.75 g

Section 55105-1 (55105-1)

Purpose

Oral anesthetic

Section 55106-9 (55106-9)

Active ingredient

Benzocaine 20% (w/w)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:10.260678 · Updated: 2026-03-14T23:00:30.367061