FDA Label for Smartmouth Mouth Sore Zinc Activated Formula
View Indications, Usage & Precautions
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 - 296 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 • 10 FL. OZ. (296 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES
* Please review the disclaimer below.