Topicale Xtra BENZOCAINE MEDICAL PRODUCTS LABORATORIES,INC. FDA Approved For the temporary relief of minor pain irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedure, minor irritation caused by dentures or orthodontic appliances
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Substance Benzocaine
Route
ORAL
Applications
M022
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Benzocaine 20%
Inactive Ingredients
Benzalkonium Chloride (as a preservative) Carbomers D&C Red Dye # 40 Flavorings Polyethylene Glycol Purified Water Saccharin Sodium
Strengths
20 %
Treats Conditions
For The Temporary Relief Of Minor Pain Irritation Associated With Minor Injury Of The Mouth And Gums Canker Sores Minor Dental Procedure Minor Irritation Caused By Dentures Or Orthodontic Appliances

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
U3RSY48JW5
Packaging

Package Carton Package Label

Package Descriptions
  • Package Carton Package Label

Overview

For the temporary relief of minor pain irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedure, minor irritation caused by dentures or orthodontic appliances

Indications & Usage

For the temporary relief of minor pain irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedure, minor irritation caused by dentures or orthodontic appliances

Dosage & Administration

Adults and children 12 years or older - Apply to the affected area. Allow to remain in place at least one minute and the spit out. Use up to 4 times daily or as directed by a dentist or doctor. Children 2-12 years of age - Should be supervised in the use of the product. Children under 2 years of age - Do not use.

Warnings & Precautions
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, grey or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or light headedness, fatigue or lack of energy. Contraindications: Do not use in large quantities or over large areas of body Do not use for Teething Do not use in children under 2 years of age Allergy Alert: Do not use if you have a history of allergy to local anesthetics such as benzocaine, butacaine, procaine or other "caine" anesthetics When using this product Avoid contact with eyes In case of accidental overdose, get medical help or contact a Poison Control Centre immediately. Do not use more than directed. Stop use and ask a doctor 1. If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting 2. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens
Purpose

Oral Anesthetic

Keep Out of Reach of Children

In case of accidental overdose, get medical help or contact a Poison Control Centre immediately. Do not use more than directed.


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