FDA Label for Leader Oral Pain Relief Anesthetic
View Indications, Usage & Precautions
Leader Oral Pain Relief Anesthetic Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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.
Active Ingredient
Benzocaine, 20%
Purpose
Oral pain reliever
Uses
For the temporary relief of minor toothache, pain and sore mouth associated with canker sores, dentures and orthodontic appliances.
Warnings
Warnings
Indications & Usage
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.
Otc - Do Not Use
Do Not Use
- more than directed
- for more than 7 days unless directed by a dentist or doctor.
Otc - Stop Use
Stop use and ask a Doctor if:
- swelling, rash, or fever develops
- irritation, pain or redness persists or gets worse
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.
Directions
Cut open tip of tube.
Adults and children 2 years of age and older, apply to affected area 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 the product.
Children under 2 years of age, consult a doctor.
Other Information
- Do not use if tube tip is cut prior to opening.
- Store at room temperature.
Inactive Ingredients
Flavors, PEG 4, PEG 540, PEG 75, PEG 8, Sodium Saccharin, Sorbic Acid.
Package Label.Principal Display Panel
Maximum Strength
Oral Pain Relief
Anesthetic Gel
ORAL PAIN RELIVER
BENZOCAINE 20%
0.5OZ (14.2G)
carton image
Maximum Strength
Oral Pain Relief
Anesthetic Gel
ORAL PAIN RELIVER
BENZOCAINE 20%
0.5OZ (14.2G)
tube image
* Please review the disclaimer below.