SPL v6
SPL
SPL Set ID e21abfdd-373d-42af-9535-fe1571382a65
Route
ORAL
Published
Effective Date 2024-06-27
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 2006-01-30 Until 2006-02-01
Description

Drug Facts

Purpose

Oral Pain Reliever

Medication Information

Purpose

Oral Pain Reliever

Description

Drug Facts

Uses
  • temporary relief of occasional minor irritation, pain and sore mouth
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.

Directions
  • do not use tube if it is cut prior to opening
  • cut open tip of tube on score mark
  • use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel
  • apply to affected area up to four times daily or as directed by a dentist or physician
  • Adults and children 2 years of age and older: Apply to affected area
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 years of age: Consult a doctor
Do Not Use
  • more than directed
  • for more than 7 days unless told to do so by a dentist or doctor
Active Ingredient

Benzocaine 20%

Other Information
  • store at a controlled room temperature 59°-86°F (15°-30°C)
Inactive Ingredients

Flavor, PEG 540, PEG 6, PEG 75, PEG 8, Sodium Saccharin, Sorbic Acid

Stop Use and Ask A Doctor If
  • swelling, rash or fever develops
  • irritation, pain, or redness persists or worsens
Principal Display Panel – 0.33oz Carton Label

Sheffield Pharmaceuticals             NDC 11527-062-47

Oral Pain Relief

Maxium Strength GEL

Fast Toothache Pain Reliever

20% Benzocaine Topical Gel 

NET WT. 0.33 OZ (9.35g)

Made in the USA

Structured Label Content

Uses
  • temporary relief of occasional minor irritation, pain and sore mouth
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.

Purpose

Oral Pain Reliever

Directions
  • do not use tube if it is cut prior to opening
  • cut open tip of tube on score mark
  • use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel
  • apply to affected area up to four times daily or as directed by a dentist or physician
  • Adults and children 2 years of age and older: Apply to affected area
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 years of age: Consult a doctor
Do Not Use (Do not use)
  • more than directed
  • for more than 7 days unless told to do so by a dentist or doctor
Active Ingredient

Benzocaine 20%

Other Information (Other information)
  • store at a controlled room temperature 59°-86°F (15°-30°C)
Inactive Ingredients (Inactive ingredients)

Flavor, PEG 540, PEG 6, PEG 75, PEG 8, Sodium Saccharin, Sorbic Acid

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • swelling, rash or fever develops
  • irritation, pain, or redness persists or worsens
Principal Display Panel – 0.33oz Carton Label

Sheffield Pharmaceuticals             NDC 11527-062-47

Oral Pain Relief

Maxium Strength GEL

Fast Toothache Pain Reliever

20% Benzocaine Topical Gel 

NET WT. 0.33 OZ (9.35g)

Made in the USA

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:35.312823 · Updated: 2026-03-14T23:07:36.685051