DOSAGE & ADMINISTRATION SECTION.
DIRECTIONS. adults and children years of age and olderapply to the 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 product.children under years of agedo not use.
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INACTIVE INGREDIENT SECTION.
INACTIVE INGREDIENTS. ammonium glycrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water.
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INDICATIONS & USAGE SECTION.
USES. for the temporary relief of pain due to minor irritation or injury of the mouth and gums occasional sore mouth and sore throat.
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OTHER SAFETY INFORMATION.
OTHER INFORMATION. do not use if package has been opened.
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OTC - ACTIVE INGREDIENT SECTION.
ACTIVE INGREDIENTS. Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%.
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OTC - DO NOT USE SECTION.
DO NOT USE. more than directedo for more than days unless directed by dentist or doctor for teethingo 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 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 DENTIST OR DOCTOR IF. sore throat is severe, persists for more than dayso sore mouth symptoms do not improve in dayso headache, nausea, vomiting, swelling, rash or fever developso irritation, pain or redness persists or worsens.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
1 ORAL PAINRELIEF BRANDFOR ADULTSOrajel(TM)TOOTHACHE GUMIMMEDIATE RELIEF OF:ORAL PAINBRACE/DENTURE IRRITATIONGUM DISCOMFORTCANKER SORESRESCUE RELIEF PENGENTLE. TARGETED. TOUCH-FREE.PLUS COOLING RELIEF50+ USESORAL PAIN RELIEVER ASTRINGENTNET WT 0.07 OZ (2.0 g). Orajel Pen.
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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 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:o 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 DO NOT USE. more than directedo for more than days unless directed by dentist or doctor for teethingo in children under years of age. STOP USE AND ASK DENTIST OR DOCTOR IF. sore throat is severe, persists for more than dayso sore mouth symptoms do not improve in dayso headache, nausea, vomiting, swelling, rash or fever developso irritation, pain or redness persists or worsens. 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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