SmartMouth™ Mouthwash Mouth Sore Zinc Activated Formula

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Menthol 0.2% (when mixed as directed)

Purpose

Oral Pain Reliever

Uses

For the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.

For the temporary relief of pain associated with:

• Canker sores
• Minor dental procedures
• Minor irritation or injury of the mouth or gums
• Minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Warnings

OTC - DO NOT USE SECTION

Do not use this product for more than 7 days unless directed by a dentist or healthcare provider

OTC - WHEN USING SECTION

When using this product do not swallow

• do not exceed recommended dosage

Stop use and see your physician promptly if

• swelling, rash or fever develops
• irritation, pain or redness persists or worsens
• sore mouth symptoms do not improve in 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Directions

• Adults and children 12 years of age & older: Swish 20mL of rinse (pour to indicator line on cup) around the mouth over the affected area for at least 1 minute, gargle and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.
• Children 6 years to under 12 years of age should be supervised in the use of this product.
• Children under 6 years of age: do not use.

Inactive Ingredients

Solution 1: Purified Water, Sodium Benzoate, Sodium Chlorite, and Benzoic Acid. Solution 2: Purified Water, Sorbitol, Poloxamer 407, Glycerin, Propylene Glycol, Poloxamer 124, Zinc Chloride, Flavor, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Peppermint Oil, Benzoic Acid, Aloe Extract, Sodium Chloride, D&C Yellow No. 10, FD&C Blue No. 1

Questions?

1-800-492-7040

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:TRIUMPH PHARMACEUTICALS INC.ST. LOUIS, MISSOURI 63141