LISTERINE SMART RINSE ANTICAVITY FLUORIDE RINSE - BERRY SPLASH- sodium fluoride mouthwash

Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash by

Drug Labeling and Warnings

Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. 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

Use

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 6 years of age and older:
• Use twice a day 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
• Instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
• Supervise children as necessary until capable of using without supervision
• Children under 6 years of age: consult a dentist or doctor

Other information

• Store at room temperature
• Cold weather may temporarily cloud this product

Inactive ingredients

Water, Sorbitol, Flavor, Phosphoric Acid, Cetylpyridinium Chloride, Sucralose, Sodium Saccharin, Disodium Phosphate, Red 33, Green 3

Questions?

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

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

2X STRONGER TEETH FOR

BETTER CAVITY PROTECTION*

*with brushing, in a lab study.

ALCOHOL FREE

ANTICAVITY FLUORIDE RINSE

LISTERINE ®

SMART RiNSE ®

SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION

BERRY

SPLASH

500 mL (16.9Fl Oz)

IMPORTANT: Read

directions for proper use.

INGREDIENTS AND APPEARANCE

LISTERINE SMART RINSE ANTICAVITY FLUORIDE RINSE - BERRY SPLASH 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0687
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
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PHOSPHORIC ACID (UNII: E4GA8884NN)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0687-5	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/01/2021

Labeler - Johnson & Johnson Consumer Inc. (118772437)