Otc - Active Ingredient
Benzocaine 20%
Nbe Anbesol Gel
FDA Label NDC 0363-0316
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Nbe Anbesol (NDC 0363-0316). 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, other safety information, 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
temporarily relieves pain associated with mouth and gum irritations
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 you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics
Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age
Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
to open tube, cut tip of tube on score mark * adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist/doctor * children under 12 years of age: adult supervision should be given in the use of this product * children under 2 years of age: do not use * for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
Other Safety Information
store at 20-25C (68-77F). Do not refrigerate.
Inactive Ingredient
blue 1, carbomer, flavor, glycerin, polyethylene glycol, propylene glycol, red 40, sodium saccharin, sorbic acid, water, yellow 10
* Please review the disclaimer below.
