INDICATIONS & USAGE SECTION.

Use. for the temporary relief of pain due to 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.

Active ingredients. Benzocaine 20%Menthol 0.26%Zinc chloride 0.15%.

DOSAGE & ADMINISTRATION SECTION.

Directions. Adults and children years of age and olderApply 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.

INACTIVE INGREDIENT SECTION.

Inactive ingredients. ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water.

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.

OTC - PURPOSE SECTION.

Purpose. 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. 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Principal Display Panel. ORAL PAINRELIEVER BRANDFOR ADULTSOpen Tube TipOrajelGUM PAIN3X MEDICATED GELINSTANT PAIN RELIEF20% Benzocaine to Relieve Gum PainCooling Relief to Soothe GumsRelieves Gum IrritationORAL PAIN RELIEVER/ASTRINGENTNET WT0.125oz (3.5g). CR2DA2044058OJFC-00500-0172016656.

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: 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.