SMARTMOUTH MOUTHWASH SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA- menthol, unspecified form kit

SmartMouth Mouthwash by

Drug Labeling and Warnings

SmartMouth Mouthwash by is a Otc medication manufactured, distributed, or labeled by Triumph Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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: supervise use.
• Children under 6 years of age: do not use unless directed by a healthcare professional.

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

PRINCIPAL DISPLAY PANEL - Kit Bottle Label

NEW &
IMPROVED
POUR

MIXES TO
ACTIVATE
2 Powerful Solutions

BLOCKS
ODORS

FRESHENS
BREATH

smart
mouth™

Mouth Sore

Scientifically Proven
Smart-Zinc™ Technology

24
HOUR

BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Oral Pain Relief For

CANKER SORES & CHEEK BITES

GUM, BRACES & DENTURE IRRITATION

COOL MINT 16 FL. OZ. (473 mL) ALCOHOL FREE

INGREDIENTS AND APPEARANCE

SMARTMOUTH MOUTHWASH   SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA
menthol, unspecified form kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76357-419

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76357-419-00	1 in 1 CARTON	01/01/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	237 mL
Part 2	1 BOTTLE	237 mL

Part 1 of 2

SMARTMOUTH MOUTHWASH   MOUTH SORE SOLUTION 1
mouthwashes and breath fresheners (liquids and sprays) [oral products]

Product Information
Route of Administration	DENTAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Sodium Chlorite (UNII: G538EBV4VF)
INGR	Benzoic Acid (UNII: 8SKN0B0MIM)
COLR	WHITE ()

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		01/01/2025

Part 2 of 2

SMARTMOUTH MOUTHWASH   MOUTH SORE SOLUTION 2
menthol, unspecified form liquid

Product Information
Item Code (Source)	NDC: 76357-489
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Poloxamer 407 (UNII: TUF2IVW3M2)
Propylene Glycol (UNII: 6DC9Q167V3)
Aloe (UNII: V5VD430YW9)
Poloxamer 124 (UNII: 1S66E28KXA)
Zinc Chloride (UNII: 86Q357L16B)
Sodium (UNII: 9NEZ333N27)
Benzoic Acid (UNII: 8SKN0B0MIM)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sodium Chloride (UNII: 451W47IQ8X)
Benzyl Alcohol (UNII: LKG8494WBH)
Sorbitol (UNII: 506T60A25R)
Peppermint (UNII: V95R5KMY2B)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT (Mild Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76357-489-02	237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M022	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M022	01/01/2025

Labeler - Triumph Pharmaceuticals, Inc. (017853461)