Red Cross Canker Sore BENZOCAINE THE MENTHOLATUM COMPANY FDA Approved Uses temporarily relieves pain and minor irritation of the mouth and gums due to ▪ canker sores ▪ minor dental procedures ▪ braces ▪ dentures
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Substance Benzocaine
Route
TOPICAL
Applications
M022
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Benzocaine 20%
Inactive Ingredients
Inactive Ingredients aloe barbadensis leaf extract butylated hydroxytoluene carbomer hompolymer cetylpyridinium chloride chamomilla recutita (matricaria) flower extract cocos nucifera (coconut) oil commiphora myrrha resin dimethicone echinacea purpurea extract flavor glyceryl stearate menthol mineral oil silica dimethicone silylate vitamin E white petrolatum
Strengths
20 %
Treats Conditions
Uses Temporarily Relieves Pain And Minor Irritation Of The Mouth And Gums Due To Canker Sores Minor Dental Procedures Braces Dentures

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
U3RSY48JW5
Packaging

Package/Label Principal Display Panel Red Cross Canker Sore Oral Anesthetic/Analgesic; Principal Display Panel

Package Descriptions
  • Package/Label Principal Display Panel Red Cross Canker Sore Oral Anesthetic/Analgesic
  • Principal Display Panel

Overview

Uses temporarily relieves pain and minor irritation of the mouth and gums due to ▪ canker sores ▪ minor dental procedures ▪ braces ▪ dentures

Indications & Usage

Uses temporarily relieves pain and minor irritation of the mouth and gums due to ▪ canker sores ▪ minor dental procedures ▪ braces ▪ dentures

Dosage & Administration

Directions snip off tip of tube apply to affected area; carefully coat with a protective layer supervise children using this product adults and children 2 years and over: use up to 4 times daily or as directed by a doctor children under 2 years: 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 Do Not Use for teething in children under 2 years of age When using this product do not use for more than 7 days unless directed by a dentist or doctor do not exceed recommended dosage Stop use and ask a doctor if sore mouth symptoms last more than 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops
Purpose

Purpose Oral anesthetic/analgesic

Do Not Use

Do Not Use for teething in children under 2 years of age

When Using

When using this product do not use for more than 7 days unless directed by a dentist or doctor do not exceed recommended dosage

Stop Use & Ask a Doctor

Stop use and ask a doctor if sore mouth symptoms last more than 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops

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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