FDA Label for Smartmouth Clinical Gum And Plaque Formula

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENT
PURPOSE
USES
OTC - ASK DOCTOR
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS
PRINCIPAL DISPLAY PANEL - 473 ML BOTTLE LABEL
PRINCIPAL DISPLAY PANEL - 946 ML BOTTLE LABEL

Smartmouth Clinical Gum And Plaque 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 63114

Active Ingredient

Cetylpyridinium Chloride 0.05% (when mixed as directed)

Purpose

Anti-gingivitis/Anti-plaque

Uses

Helps prevent and reduce plaque and gingivitis. Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Otc - Ask Doctor

Ask a dentist if symptoms persist or condition worsens after regular use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age.

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 and older: vigorously swish 20 milliliters of rinse (pour to indicator line on cap) twice a day for 30 seconds and then spit out. Do not swallow.
Children 6 years to under 12 years of age: supervise use.
Children under 6 years of age: do not use.

Other Information

This rinse is not intended to replace brushing or flossing.

Inactive Ingredients

Solution 1: Purified Water, Sodium Benzoate, Sodium Chlorite, and Benzoic Acid

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

Questions Or Comments

1-800-492-7040

Principal Display Panel - 473 Ml Bottle Label

Both Liquids with a Single Pour

H₂S ELIMINATOR^∞ & Zn⁺² ACTIVATOR

smart
mouth™
OTC

Activates Zinc Ions
Blocks Sulfur Gas

Clinical DDS™

ACTIVATED ORAL RINSE™

PRESCRIPTION STRENGTH⁺
Gingivitis & Bleeding Gums Protection

24 HR
BAD BREATH
PREVENTION*

AM RINSE = ALL DAY CLEAN BREATH
PM RINSE = ELIMINATES MORNING BREATH

GUARANTEED^†

PATENTED FORMULA • DENTIST DEVELOPED

CLEAN MINT • NO AFTERTASTE • ALCOHOL FREE • SAFE FOR DIABETICS • 16 FL. OZ. (473 mL)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - smartmouth 01

Principal Display Panel - 946 Ml Bottle Label