FDA Label for Anbesol Maximum Strength
View Indications, Usage & Precautions
Anbesol Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Foundation Consumer Brands. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by: Foundation Consumer Brands, LLC
Pittsburgh, PA 15212
Active Ingredient
Benzocaine 20%
Purpose
Oral pain reliever
Uses
- temporarily relieves pain associated with the following mouth and gum irritations:
- toothache
- sore gums
- canker sores
- braces
- minor dental procedures
- dentures
Methemoglobinemia Warning
Use of this product may cause methemoglobinemia, a rare but 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
- for teething
- in children under 2 years of age
When Using This Product
- avoid contact with the eyes
- do not exceed recommended dosage
- do not use for more than 7 days unless directed by a doctor/dentist
Stop Use And Ask A Doctor If
- sore mouth symptoms do not improve in 7 days
- irritation, pain, or redness lasts or worsens
- swelling, rash, or fever develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- to open tube, cut tip of the tube on score mark with scissors
adults and children 2 years of age and over apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist 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 thin layer to the affected area
- do not reinsert dental work until irritation/pain is relieved
- rinse mouth well before reinserting
Other Information
- store at 20-25°C (68-77°F)
- do not refrigerate
Inactive Ingredients
benzyl alcohol, carbomer 934P, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin
Questions Or Comments?
Call 1-888-594-0673 weekdays 9 AM to 5 PM EST
Principal Display Panel - 9 G Tube Blister Pack
gel
Anbesol®
Oral Pain Reliever/Benzocaine 20%
MAXIMUM
STRENGTH
Instant
Pain Relief
✓ Toothaches✓ Gum Pain✓ Canker Sores✓ Denture Pain
NET WT 0.33 OZ (9 g)
* Please review the disclaimer below.