TopCare Oral Pain Relief Maximum Strength BENZOCAINE TOPCO ASSOCIATES LLC FDA Approved Use for the temporary relief of pain due to toothaches
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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 flavor polyethylene glycol sodium saccharin sorbic acid
Strengths
20 %
Treats Conditions
Use For The Temporary Relief Of Pain Due To Toothaches

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
U3RSY48JW5
Packaging

Carton R4

Package Descriptions
  • Carton R4

Overview

Use for the temporary relief of pain due to toothaches

Indications & Usage

Use for the temporary relief of pain due to toothaches

Dosage & Administration

Directions cut open tip of tube on scoremark adults and children 2 years of age and older: apply a small amount of product to the cavity and around the the gum surrounding the teeth. 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 this 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 Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor for teething in children under 2 years of age Stop use and ask a doctor if swelling, rash, fever develops irritation, pain or redness persists or worsens symptoms do not improve in 7 days allergic reaction occurs Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Purpose Oral Pain Reliever

Do Not Use

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

Stop Use & Ask a Doctor

Stop use and ask a doctor if swelling, rash, fever develops irritation, pain or redness persists or worsens symptoms do not improve in 7 days allergic reaction occurs

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


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