FDA Label for Smartmouth Mouth Sore Zinc Activated Formula

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENT
PURPOSE
USES
OTC - DO NOT USE
OTC - WHEN USING
STOP USE AND SEE YOUR PHYSICIAN PROMPTLY IF
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
INACTIVE INGREDIENTS
QUESTIONS?
PRINCIPAL DISPLAY PANEL - 437 ML KIT CELLO PACK
PRINCIPAL DISPLAY PANEL - 296 ML KIT CELLO PACK

Smartmouth Mouth Sore Zinc Activated Formula Product Label

The following document was submitted to the FDA by the labeler of this product Triumph Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

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

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

Otc - Do Not Use

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

Otc - When Using

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

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

Principal Display Panel - 437 Ml Kit Cello Pack

MIXES TO ACTIVATE
2 Powerful Solutions

smart
mouth™

Mouth Sore
Zinc Activated Oral Rinse™

24
HOUR
BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Soothes Oral Pain & Irritation

For all Mouth Sores, Canker Sores and Cheek Bites

Relieves Gum, Braces and Denture Irritation

Zinc Promotes Oral Health & Boosts Immunity

COOL MINT • 16 FL. OZ. (473 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

PRINCIPAL DISPLAY PANEL - 437 mL Kit Cello Pack - smartmouth 01

Principal Display Panel - 296 Ml Kit Cello Pack