HurriCaine Topical Anesthetic Gel BENZOCAINE BEUTLICH PHARMACEUTICALS, LLC FDA Approved Uses for the temporary relief of occasional minor irritation and pain associated with: canker sores sore mouth and throat minor injury of the mouth and gums minor dental procedures minor irritation of the mouth and gums caused by dentures or orthodontic appliances
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Substance Benzocaine
Route
DENTAL ORAL PERIODONTAL
Applications
M022

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Benzocaine 20%
Inactive Ingredients
Inactive ingredients flavor polyethylene glycol sodium saccharin
Strengths
20 %
Quantities
45 count
Treats Conditions
Uses For The Temporary Relief Of Occasional Minor Irritation And Pain Associated With Canker Sores Sore Mouth And Throat Minor Injury Of The Mouth And Gums Minor Dental Procedures Minor Irritation Of The Mouth And Gums Caused By Dentures Or Orthodontic Appliances
Pill Appearance
Color: yellow

Identifiers & Packaging

Container Type BOX
UNII
U3RSY48JW5
Packaging

Principal Display Panel HurriCaine Unit Dose Gel Pina Colada 0.5g with Swab: 0283-0886-45 60ct HurriCaine Unit Dose Gel Pina Colada 0.5g with Swab: 0283-0886-59 unit dose gel Pina Colada 60ct box unit dose gel Pina Colada

Package Descriptions
  • Principal Display Panel HurriCaine Unit Dose Gel Pina Colada 0.5g with Swab: 0283-0886-45 60ct HurriCaine Unit Dose Gel Pina Colada 0.5g with Swab: 0283-0886-59 unit dose gel Pina Colada 60ct box unit dose gel Pina Colada

Overview

Uses for the temporary relief of occasional minor irritation and pain associated with: canker sores sore mouth and throat minor injury of the mouth and gums minor dental procedures minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Indications & Usage

Uses for the temporary relief of occasional minor irritation and pain associated with: canker sores sore mouth and throat minor injury of the mouth and gums minor dental procedures minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Dosage & Administration

Directions Directions: • do not exceed recommended dosage adults and children 2 years of age and older: apply to the affected area. Allow to remain in place at least 1 minute and then spit out. 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

Warnings & Precautions
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.
Purpose

Purpose Oral Anesthetic

When Using

When using this product When using this product : avoid contact with eyes

Stop Use & Ask a Doctor

Do Not Use Do not use • if product film is punctured or damaged • for teething • in children under 2 years of age

Keep Out of Reach of Children

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 immediately.

Storage & Handling

Storage and Handling store at 20°-25°C (68°-77°F)

Questions

Questions or comments? 1-800-238-8542 M-F: 8:00 a.m. to 4:30 p.m. ET


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