Otc - Active Ingredient
Active Ingredient Purpose
Benzocaine 20%................................Oral pain reliever
Quality Choice Gel
FDA Label NDC 83324-299
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 (NDC 83324-299). 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 - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- for the temporary relief of pain due for:
- toothache
- canker sores
- gum pain
- denture pain
- cheek bites
Warnings
Warnings
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried blood. This can occur even I you have used this product before. Stop use and seek immediate medical attention if you are a child in your care develops:
- pale, gay, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheartedness
- fatigue or lack of energy
​Allergy Alert: do not use this product if you have a history of allergy to local anethetics as procaine, bucaine, 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
- for teething
- in children under 2 years of age
Otc - Stop Use
Stop use and ask a doctor if
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness does not go away
- swelling, rash or fever develops
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose or allergic reaction, seek medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
Directions
| Adults and children 2 years of age and older | Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor. |
| Children under 12 years of age | Should be supervised in the use of this product |
| Children under 2 years of age | Do not use |
Storage And Handling
Other information
- store at room temperature 20-25° (68-77°F)
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted. Do not use continuously.
Inactive Ingredient
Inactive ingredient glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol
Dosage & Administration
Distributed by CDMA, INC
Novi, MI 48375
Made in China
Package Label.Principal Display Panel
95362 (95362.1)
* Please review the disclaimer below.
