DOSAGE & ADMINISTRATION SECTION.
Directions. Adults and children years of age and overApply to affected area up to times daily or as directed by dentist or doctorChildren between and 12 years of ageAsk doctor before use. Should be supervised in the use of this productChildren under years of ageDo not use. Apply to affected area up to times daily or as directed by dentist or doctor. Ask doctor before use. Should be supervised in the use of this product. Do not use.
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INACTIVE INGREDIENT SECTION.
Inactive Ingredients. ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water.
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INDICATIONS & USAGE SECTION.
Use. for the temporary relief of pain due to minor irritation or injury of the mouth and gumsfirst aid to help prevent infection in minor oral irritation. 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.
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OTHER SAFETY INFORMATION.
Other Information. do not use if Tamper-Evident tab is open before first useavoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying. do not use if Tamper-Evident tab is open before first use. avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying.
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OTC - ACTIVE INGREDIENT SECTION.
Active Ingredients. Belzalkonium chloride 0.13%Benzocaine 20%Menthol 0.5%Zinc chloride 0.15%.
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OTC - DO NOT USE SECTION.
Do not use. more than directedfor more than days unless directed by dentist or doctorfor teethingin children under years of age. more than directed. for more than days unless directed by dentist or doctor. for teething. in children under years of age.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact Poison Control Center right away.
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OTC - PURPOSE SECTION.
Purpose. Oral antiseptic, Oral pain reliever, Oral astringent.
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OTC - QUESTIONS SECTION.
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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OTC - STOP USE SECTION.
Stop use and ask doctor if. symptoms do not improve in daysswelling, rash or fever developsirritation, pain or redness persists or worsens. symptoms do not improve in days. swelling, rash or fever develops. irritation, pain or redness persists or worsens.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel. ORAL PAIN RELIEVER BRAND FOR TOOTHACHEReady-Open Tube TipOrajel4X MEDICATED FOR TOOTHACHE AND GUM GELINSTANT PAIN RELIEFClinical Strength for Pain ReliefProven to Kill Harmful BacteriaHelps Prevent InfectionCooling Relief for Gum IrritationORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENTNET WT0.25 oz (7.0 g). OJFC-32503-08.jpg.
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WARNINGS SECTION.
Warnings. Methemoglobinemia warning: Use of this product may cause methemoglobinemia, serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or 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 history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other caine anesthetics.
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