Otc - Active Ingredient
Active ingredient Purpose
Benzocaine 20%..........................................................................Oral pain reliever
Quality Choice Maximum Strength Oral Pain Relieving
FDA Label NDC 63868-477
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 63868-477). 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 temporarily relieves pain due to:
- 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 in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Allergy alert: do not use this product if your child has a history of allergy 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
- 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 persists or worsens
- 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 cases of overdose, get medical help or contact a Poison Control Center right away.
Indications & Usage
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° to 25°C (68° to 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 ingredients
glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol
Dosage & Administration
Distributed By C.D.M.A., Inc.
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Made in China
* Please review the disclaimer below.
