Otc - Active Ingredient
Benzocaine 20%
Bencocaine Topical Anesthetic Spray, Metered
FDA Label NDC 66975-360
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Benco Dental for the product Bencocaine Topical Anesthetic (NDC 66975-360). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Oral Anesthetic
Indications & Usage
For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures. For Professional Use Only.
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 the 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
- for teething
- in children under 2 years of age
Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Flammable. Do not use near fire or flame. Avoid smoking during use.
Do not use:
Otc - Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away. Avoid spraying in eyes
Dosage & Administration
Apply only amount needed to the oral mucosa to prevent or relieve pain.
- Children under 2 years of age: do not use
Storage And Handling
Store at room temperature. Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.
Inactive Ingredient
Ethyl Alcohol, Flavor, Polyethelyn Glycol, Sodium Saccharin, Hydrocarbon Propellant (HFC-134a).
Package Label.Principal Display Panel
Display Panel (Label)
Design Panel (Box)
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