53cbac1e-0382-4e03-80fb-f13bcae2b3dd

SPL v2
SPL
SPL Set ID 53cbac1e-0382-4e03-80fb-f13bcae2b3dd
Route
oral
Published
Effective Date 2019-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (200 mg)
Inactive Ingredients
polyethylene glycol 300 benzyl alcohol carbomer 934 propylene glycol saccharin sodium methylparaben glycerin

Identifiers & Packaging

Marketing Status
otc monograph not final completed Since 2007-01-23 Until 2023-12-31
Purpose

Oral Pain Reliever

Description

Drug Facts

Medication Information

Uses
  • temporary relief of occasional minor irritation, pain and sore mouth
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
Other Information
  • store at a controlled room temperature 59°-86°F (15°-30°C)
Inactive Ingredients

Benzyl Alcohol, Carboer, D&C Yellow No10, FD&C Blue No1, FD&C Red No40, Flavor, Glycerin, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin

Description

Drug Facts

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.

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%

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

NDC 11527-081-28

Oral Pain Relief

MAXIMUM STRENGTH GEL

Benzocaine 20%

The Adult Medicine for Toothache

Fast Toothache Pain Reliever

NET WT. 0.33 OZ (9.35g)

Principal Display Panel – 0.33oz Carton Label

NDC 11527-081-28

Oral Pain Relief

MAXIMUM STRENGTH GEL

Benzocaine 20% NET WT. 0.33 OZ (9.35g)

Structured Label Content

Uses
  • temporary relief of occasional minor irritation, pain and sore mouth
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
Other Information (Other information)
  • store at a controlled room temperature 59°-86°F (15°-30°C)
Inactive Ingredients (Inactive ingredients)

Benzyl Alcohol, Carboer, D&C Yellow No10, FD&C Blue No1, FD&C Red No40, Flavor, Glycerin, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin

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.

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%

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 Tube Label

NDC 11527-081-28

Oral Pain Relief

MAXIMUM STRENGTH GEL

Benzocaine 20%

The Adult Medicine for Toothache

Fast Toothache Pain Reliever

NET WT. 0.33 OZ (9.35g)

Principal Display Panel – 0.33oz Carton Label

NDC 11527-081-28

Oral Pain Relief

MAXIMUM STRENGTH GEL

Benzocaine 20% NET WT. 0.33 OZ (9.35g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:30.127961 · Updated: 2026-03-14T22:58:03.704124