Finafta BENZOCAINE GLYCERIN EFFICIENT LABORATORIES INC. FDA Approved Uses For temporary relief of pain associated with canker sores
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Substance Benzocaine
Route
TOPICAL
Applications
M022
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients: (%) Purpose Benzocaine USP 5%..................Oral Anesthetic Glycerin 33% .........................Oral Demulcen
Inactive Ingredients
Inactive Ingredients: menthol methylparaben polyethylene glycol propylparaben propylene glycol purified water phosphoric acid sucralose.
Strengths
33 %
Treats Conditions
Uses For Temporary Relief Of Pain Associated With Canker Sores

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
U3RSY48JW5 PDC6A3C0OX
Packaging

label

Package Descriptions
  • label

Overview

Uses For temporary relief of pain associated with canker sores

Indications & Usage

Uses For temporary relief of pain associated with canker sores

Dosage & Administration

Directions •adults and children over 12 years of age apply to the affected area, mouth, gums or mucous membrane with the applicator provided, up to 4 times daily or as directed by a dentist or doctor. Remain in place at least 1 minute and then spit out. Do not rinse mouth after each use • Children between 2 and 12 years of age: consult a doctor •children under 12 years of age should be supervised in the use of the product •do not use in children under 2 years of age.

Warnings & Precautions
Warnings Do not exceed recommended dosage 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 the 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 t his product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
Purpose

Purpose Oral Anesthetic Oral Demulcen

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental overdose: Get medical help or contact a Poison Control Center right away.

Questions

Questions or comments? 305-805-3456 Monday-Friday (9 a.m. - 5 p.m. EST) www.efficientlabs.com


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