Orajel 4X Medicated For Toothache and Gum, Cream BENZALKONIUM CHLORIDE BENZOCAINE MENTHOL ZINC CHLORIDE CHURCH & DWIGHT CO., INC. FDA Approved Uses for the temporary relief of pain due to minor irritation or injury of the mouth and gums first aid to help prevent infection in minor oral irritation
FunFoxMeds box
Route
TOPICAL
Applications
M022
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients Benzalkonium chloride 0.13% Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%
Inactive Ingredients
Inactive ingredients ammonium glycyrrhizate flavor PEG-8 PEG-75 PEG/PPG 116/66 copolymer poloxamer 407 sodium saccharin sorbic acid titanium dioxide water
Strengths
0.13 % 20 % 0.26 % 0.15 %
Treats Conditions
Uses For The Temporary Relief Of Pain Due To Minor Irritation Or Injury Of The Mouth And Gums First Aid To Help Prevent Infection In Minor Oral Irritation

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
F5UM2KM3W7 U3RSY48JW5 L7T10EIP3A 13S1S8SF37
Packaging

Principal Display Panel #1 ORAL PAIN RELIEVER FOR TOOTHACHES Ready-Open Tube Tip Orajel 4X MEDICATED FOR TOOTHACHE AND GUM INSTANT PAIN RELIEF CREAM Clinical Strength Pain Relief Proven to Kill Harmful Bacteria Helps Prevent Infection Cooling Relief for Gum Irritation ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT NET WT 0.33 OZ (9.4 g) DA2009001_OJFC-32501-10_72013318

Package Descriptions
  • Principal Display Panel #1 ORAL PAIN RELIEVER FOR TOOTHACHES Ready-Open Tube Tip Orajel 4X MEDICATED FOR TOOTHACHE AND GUM INSTANT PAIN RELIEF CREAM Clinical Strength Pain Relief Proven to Kill Harmful Bacteria Helps Prevent Infection Cooling Relief for Gum Irritation ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT NET WT 0.33 OZ (9.4 g) DA2009001_OJFC-32501-10_72013318

Overview

Uses for the temporary relief of pain due to minor irritation or injury of the mouth and gums first aid to help prevent infection in minor oral irritation

Indications & Usage

Uses for the temporary relief of pain due to minor irritation or injury of the mouth and gums first aid to help prevent infection in minor oral irritation

Dosage & Administration

Directions Adults and children 2 years of age and older Apply to affected area up to 4 times daily or as directed by a dentist or doctor Children between 2 and 12 years of age Ask a doctor before use. 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
Purpose

Purpose Oral antiseptic, Oral pain reliever, Oral astringent

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

Stop Use & Ask a Doctor

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

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

Questions

Questions or comments? call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com


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