Rite Aid Maximum Toothache Relief Double Med Gel

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzocaine 20%

Menthol 0.26%

OTC - PURPOSE SECTION

Purpose

Oral Pain Reliever

Oral Pain Reliever

INDICATIONS & USAGE SECTION

Use

• for the temporary relief of pain due to toothaches
• to help protect against infection of minor oral irritation

WARNINGS SECTION

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:

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

• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

OTC - DO NOT USE SECTION

Do not use

• more than directed
• for more than 7 days unless told to do so by a dentist or doctor
• for teething
• in children under 2 years of age

OTC - STOP USE SECTION

Stop use and ask a doctor if

• swelling, rash or fever develops
• irritation, pain or redness persists or worsens
• symptoms do not improve in 7 days
• allergic reaction occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

• cut open tip of tube on score mark
• do not use if tip is cut prior to opening
• 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 under 12 years of age should be supervised in the use of this product
• children under 2 years of age: do not use

OTHER SAFETY INFORMATION

Other information

• do not use if tip is cut prior to opening
• this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
• do not use continuously
• this formula will stay in place for extended duration of relief
• avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

INACTIVE INGREDIENT SECTION

Inactive ingredientsAmmonium Glycyrrhizate, Flavor, Polyethylene Glycol, Sodium Saccharin, Sorbic Acid

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

TAMPER EVIDENT: Do not use if tube tip is cut prior to use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RITE AID® PHARMACY

MAXIMUM toothache reliever

immediate relief of toothache pain

Fast acting GEL

ORAL PAIN RELIEVER

Double Medicated

NET WT 0.42 OZ (12 g)

• 20% Benzocaine for toothache pain relief
• Menthol to sooth gums