Oral Pain Relief BENZOCAINE AND BENZALKONIUM CHLORIDE UNIVERSAL DISTRIBUTION CENTER LLC FDA Approved Use ■ for the temporary relief of pain due to toothaches ■ to help protect against infection in minor oral irritation

ORAL PAIN RELIEF

Generic: BENZOCAINE AND BENZALKONIUM CHLORIDE
Mfr: UNIVERSAL DISTRIBUTION CENTER LLC FDA OTC
FunFoxMeds box
Substance Benzalkonium Chloride
Route
TOPICAL
Applications
M022
Product NDC
52000-0060-00 52000-0060-02
Package NDC
52000-060-02

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients Benzocaine 20% Benzalkonium Chloride 0.1%
Inactive Ingredients
Inactive ingredients ammonium glycyrrhizate flavor polyethylene glycol sodium saccharin sorbic acid purified water FD&C Yellow#5 FD&C Red#40
Strengths
20 % 0.1 %
Treats Conditions
Use For The Temporary Relief Of Pain Due To Toothaches To Help Protect Against Infection In Minor Oral Irritation

Identifiers & Packaging

Container Type UNKNOWN
NDC 52000-0060-00
All Product Codes
52000-0060-00 52000-0060-02
UNII
F5UM2KM3W7 U3RSY48JW5
SPL Set IDs
18520f9b-4d35-1e9c-e063-6294a90aaa39
Packaging

Package Label Oral Pain Relief Gel NET WT. 0.5 oz (14 g) oralgel-2

Package Descriptions
  • Package Label Oral Pain Relief Gel NET WT. 0.5 oz (14 g) oralgel-2
Overview

Use ■ for the temporary relief of pain due to toothaches ■ to help protect against infection in minor oral irritation

Indications & Usage

Use ■ for the temporary relief of pain due to toothaches ■ to help protect against infection in minor oral irritation

Dosage & Administration

Directions ■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider ■ 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 reduce 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 lightheadness • 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 or other "caine" anesthetics
Purpose

Purpose Oral pain reliever Antiseptic

Do Not Use

Do not use ■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

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

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Additional Information

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