LISTERINE CLINICAL SOLUTIONS ENAMEL STRENGTH ALPINE MINT- sodium fluoride mouthwash

Listerine Clinical Solutions Enamel Strength Alpine Mint by

Drug Labeling and Warnings

Listerine Clinical Solutions Enamel Strength Alpine Mint by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium Fluoride 0.02% (0.01% w/v Fluoride Ion)

Purpose

Anticavity

Uses

aids in the prevention of dental cavities

Warnings

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 and older:

• use twice daily after brushing your teeth with a toothpaste
• vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
• do not swallow the rinse
• do not eat or drink for 30 minutes after rinsing
• supervise children as necessary until capable of using without supervision

Children under 12 years of age: consult a dentist or a doctor

Other information

• store at room temperature
• cold weather may cloud this product

Inactive ingredients

Water, Alcohol (21.6% v/v), Sorbitol, Poloxamer 407, Flavor, Sodium Lauryl Sulfate, Eucalyptol, Sodium Saccharin, Methyl Salicylate, Thymol, Phosphoric Acid, Menthol, Sucralose, Disodium Phosphate, Green 3, Yellow 10

Questions?

call toll-free 888-222-0182 or 215-273-8755 (collect)

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Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

ANTICAVITY FLUORIDE MOUTHWASH

LISTERINE ®

CLINICAL

SOLUTIONS †

IMPORTANT: READ DIRECTIONS FOR PROPER USE

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

ENAMEL STRENGTH

Repairs enamel and prevents cavities

for stronger*, longer lasting teeth

(*with brushing in a lab study)

ALPINE MINT

1L (1 Qt 1.8 Fl Oz)

INGREDIENTS AND APPEARANCE

LISTERINE CLINICAL SOLUTIONS ENAMEL STRENGTH ALPINE MINT 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0881
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
EUCALYPTOL (UNII: RV6J6604TK)
MENTHOL (UNII: L7T10EIP3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0881-1	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/26/2024
2	NDC: 69968-0881-9	95 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/26/2024
3	NDC: 69968-0881-5	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	02/26/2024

Labeler - Kenvue Brands LLC (118772437)