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.

INACTIVE INGREDIENT SECTION.

allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water.

INDICATIONS & USAGE SECTION.

Use. for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums.

OTHER SAFETY INFORMATION.

Other information. do not use if Tamper-Evident Tab is open before first use.

OTC - ACTIVE INGREDIENT SECTION.

Benzocaine 20%Menthol 0.1%Zinc Chloride 0.15%.

OTC - DO NOT USE SECTION.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

In case of overdose or allergic reaction, get medical help or contact Poison Control Center right away.

OTC - PURPOSE SECTION.

Oral pain reliever and Oral astringent.

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.

OTC - STOP USE SECTION.

Stop use and ask doctor if. sore mouth symptoms do not improve in daysswelling, rash or fever developsirritation, pain or redness persists or worsens. sore mouth symptoms do not improve in days. swelling, rash or fever develops. irritation, pain or redness persists or worsens.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

1 ORAL PAINRELIEF BRANDFOR ADULTSEXTRA STRENGTHOrajel(TM)3X MOUTH SORESMEDICATEDIMMEDIATE PAIN RELIEFORAL PAINRELIEVER/ASTRINGENTProvidesLong-LastingPain ReliefHelps Protect Soresfrom IrritationDelivers TargetedPain ReliefGELNET WT0.18 OZ (5.1 g). Orajel 3x Gel 31840.jpg.

WARNINGS SECTION.

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: 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.