Oral pain relief BENZOCAINE ALAINA HEALTHCARE PRIVATE LIMITED FDA Approved Uses temporarily relieves pain associated with the following mouth and gum irritations: toothache canker sores minor dental procedures dentures sore gums braces
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Substance Benzocaine
Route
ORAL
Applications
M022
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredients Purpose Benzocaine 20%....................................................................Oral pain reliever
Inactive Ingredients
Inactive Ingredients benzyl alcohol carbomer D&C red no. 33 FD&C blue no. 1 FD&C yellow no. 6 glycerin natural flavor polyethylene glycol polysorbate 80 propylene glycol sodium saccharin sorbic acid
Treats Conditions
Uses Temporarily Relieves Pain Associated With The Following Mouth And Gum Irritations Toothache Canker Sores Minor Dental Procedures Dentures Sore Gums Braces

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
U3RSY48JW5
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL MAXIMUM STRENGTH ORAL PAIN RELIEF GEL FAST ACTING Benzocaine 20% pain relieving gel NET WT 0.5 OZ (14g) label label

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL MAXIMUM STRENGTH ORAL PAIN RELIEF GEL FAST ACTING Benzocaine 20% pain relieving gel NET WT 0.5 OZ (14g) label label

Overview

Uses temporarily relieves pain associated with the following mouth and gum irritations: toothache canker sores minor dental procedures dentures sore gums braces

Indications & Usage

Uses temporarily relieves pain associated with the following mouth and gum irritations: toothache canker sores minor dental procedures dentures sore gums braces

Dosage & Administration

Directions: adults and children 2 years of age and over apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist children under 12 years of age adult supervision should be given in the use of this product children under 2 years of age do not use For denture irritation: apply thin layer to the affected area do not reinsert dental work until irritation/pain is relieved rinse mouth well before reinserting Other information store at 20-25°C (68-77°F) do not refrigerate

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. Do not use: 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, get medical help or contact a Poison Control Center right away.


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