5820388 Family Wellness Max Str Oral Pain Relief

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzocaine 20% (W/W)

OTC - PURPOSE SECTION

Purpose

Oral anesthetic

INDICATIONS & USAGE SECTION

Use

Temporarily relieves pain associated with the following mouth and gum irritations:

• toothache
• sore gums
• canker sores
• braces
• minor dental procedures

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

Adults and children 2 years of age and older:

children under 2 years of age: do not use

• apply to affected area using applicator tip
• use 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

STORAGE AND HANDLING SECTION

Other information

• do not use if package has been opened
• store at 20 - 25 C (68-77F)

INACTIVE INGREDIENT SECTION

Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artificial Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

SPL UNCLASSIFIED SECTION

MADE IN CANADA

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

10611 MONROE RD.

MATTHEWS, NC 28105

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY WELLNESS

MAXIMUM STRENGTH

Oral Pain Relief

20% Benzocaine

Liquid Anesthetic

0.5 FL OZ (14.7 mL)