Goodsense Oral Pain Relief Gel
FDA Label NDC 50804-191

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin And Dunn, Inc. for the product Goodsense Oral Pain Relief (NDC 50804-191). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                   Purpose

Benzocaine 20%................................................. Oral pain reliever

Otc - Purpose

Uses

Temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters, minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Warnings

Warnings

Allergy alert: do not use this product if you have a history of allergic to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Otc - Do Not Use

Do not use

  • more than directed
  • for more than 7 days unless directed by a doctor/dentist

Otc - Stop Use

Stop use and ask a doctor if

  • swelling, rash, or fever develops
  • irritation, pain, or redness persits or worsens
  • symptoms do not improve in 7 days

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Directions

  • remove cap and cut tip of tube on score mark
  • adults and children 2 years of age and older: apply a small amount of Oral Pain Relief Gel to the cavaity around gum surrounding the teeth. Use up to 4 times daily or as directed by a doctor or dentist
  • children under 12 years of age: should be supervised in the use of this product
  • children under 2 years of age: ask a doctor/dentist

Storage And Handling

Other information

  • store at 15° to 25°C (59° to 77°F)
  • do not use if tube tip is cut prior to opening
  • this preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist can be consulted
  • do not use continuously
  • lot no. & exp. date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients: flavor mint, glycerin, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

Dosage & Administration

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

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