Dolodent Maximum Strength BENZOCAINE PHARMADEL LLC FDA Approved Uses For the temporary relief of canker sores minor injury of the mouth and gums minor irritation of the mouth and gums caused by dentures or orthodontic appliances
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Substance Benzocaine
Route
TOPICAL
Applications
M022
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient and Purpose . Active ingredient Purpose Benzocaine 20%...................... Oral pain reliever
Inactive Ingredients
Inactive ingredients alcohol clove oil glycerin polyethylene glycol propylene glycol sodium saccharin sodium methylparaben
Treats Conditions
Uses For The Temporary Relief Of Canker Sores Minor Injury Of The Mouth And Gums Minor Irritation Of The Mouth And Gums Caused By Dentures Or Orthodontic Appliances

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
U3RSY48JW5
Packaging

Principal Display Panel Dolodent PDP

Package Descriptions
  • Principal Display Panel Dolodent PDP

Overview

Uses For the temporary relief of canker sores minor injury of the mouth and gums minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Indications & Usage

Uses For the temporary relief of canker sores minor injury of the mouth and gums minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Dosage & Administration

Directions adults and children 2 years of age and older: apply product to a cotton swab or finger 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 this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics. Flammable . Keep away from fire or flame. Avoid smoking during application. Do not use more than directed for more than 7 days unless directed by a dentist or doctor for teething in children under 2 years of age Stop use and ask your doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops Keep out of reach of children. If more than used for pain is accidentally swallowed or an allergic reaction occurs, get medical help or contact a Poison Control Center right away.
Purpose

Active ingredient Purpose Benzocaine 20%...................... Oral pain reliever

Do Not Use

Do not use more than directed for more than 7 days unless directed by a dentist or doctor for teething in children under 2 years of age

Keep Out of Reach of Children

Keep out of reach of children. If more than used for pain is accidentally swallowed or an allergic reaction occurs, get medical help or contact a Poison Control Center right away.

Questions

Questions or comments? +1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com


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