81417-001 My Medic Oral Pain Relief Gel

81417-001 My Medic Oral Pain Relief Gel
SPL v2
SPL
SPL Set ID e7391302-831e-14dc-e053-2a95a90ac236
Route
TOPICAL
Published
Effective Date 2022-08-29
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 DRUG Active Since 2022-08-29
Description

Active ingredient Benzocaine 20% (w/w)

Medication Information

Warnings and Precautions

Warnings

For oral use only.

Indications and Usage

Uses 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 a doctor.

Description

Active ingredient Benzocaine 20% (w/w)

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if get any discomfort.

Section 51727-6

Inactive ingredients

Polyethylene Glycol, Fragrance

Section 51945-4

Section 55105-1

Purpose

Oral anesthetic

Section 55106-9

Active ingredient

Benzocaine 20% (w/w)

Structured Label Content

Indications and Usage (34067-9)

Uses 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 a doctor.

Warnings and Precautions (34071-1)

Warnings

For oral use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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)

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:41.621143 · Updated: 2026-03-14T23:02:24.469183