FDA Label for Benzocaine
View Indications, Usage & Precautions
Benzocaine Product Label
The following document was submitted to the FDA by the labeler of this product Major� Pharmaceuticals. 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.
Drug Facts
Active Ingredient
Benzocaine 20%
Purpose
Oral Anesthetic
Indications & Usage
Uses for the temporary relief of occasional minor irritation and pain associated with sore mouth and throat
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 if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Sore throat warning:if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.
Do Not Use
- if foil pouch has been previously opened
- for teething
- in children under 2 years of age
When Using This Product
- avoid contact with eyes
Keep Out Of Reach Of Children.
If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) Immediately
Directions
- do not exceed recommended dosage
adults and children 2 years of age and older: 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 the product
children under 2 years of age: do not use
Other Information
- store at 15-30 °C (59-86 °F)
Inactive Ingredients
cherry flavor, polyethylene glycol, sucralose
Questions Or Comments?
(855) 879-4368
Principal Display Panel
MAJOR®
NDC 0904-7301-66
Benzocaine 20% Spray
Unit Dose Non-Aerosol Spray
20% Benzocaine Oral Anesthetic
25 Unit Dose Non-Aerosol Sprays
0.017 fl.oz. (0.5 mL)
MAJOR®
NDC 0904-7301-65
Benzocaine 20% Spray
Unit Dose Non-Aerosol Spray
20% Benzocaine Oral Anesthetic
1 Unit Dose Non-Aerosol Spray
0.017 fl.oz. (0.5 mL)
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