Quality Choice Maximum Strength Oral Pain Relieving Gel
FDA Label NDC 63868-953

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Quality Choice Maximum Strength Oral Pain Relieving (NDC 63868-953). 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 - when using, 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 (each gram contains)                                                       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 allergy to local anesthetics such as procaine, butacaine, bensocaine or other "caine" anesthetics.

Otc - When Using

When using this product

  • do not use more than directed
  • do not use for more than 7 days unless directed by a doctor/dentist
  • do not use more than 4 times in a 24 hour period unless directed by a doctor/dentist

Otc - Stop Use

Stop use and ask a doctor if

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In cases of overdose, get medical help or contact a Poison Control Center right away.

Indications & Usage

Directions

  • remove cap and apply small amount of Oral Pain Relieving Gel to the cavity and around gum surrounding the teeth
  • adults and children 2 years of age and older: apply to the affected area up to 4 times daily or as directed by a doctor/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
  • For denture Irritation:
  • apply thin layer to the affected area
  • do not reinsert denture work until irritation/pain is relieved
  • rinse mouth well before reinserting

Storage And Handling

Other information

  • store at 15° to 25°C (59° to 77°F)
  • Lot No. and Exp. Date: See box or crimp of tube

Inactive Ingredient

Inactive ingredients flavor, polyethylene glycols, sodium saccharin, sorbic acid

Dosage & Administration

Distributed By Quality Choice

Novi, MI 48376-0995

Made in Korea

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