LISTERINE SMART RINSE BERRY SPLASH- sodium fluoride mouthwash

Listerine Smart Rinse Berry Splash by

Drug Labeling and Warnings

Listerine Smart 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 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
• remove cap and hold bottle upright. Fill to 10 mL line by squeezing the front and back (not the sides) of the bottle. Stop squeezing. Excess liquid will drain back into the bottle. Pour in the cup.
• 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

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). www.listerine.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

NEW!
2X STRONGER TEETH
FOR BETTER CAVITY PROTECTION*
ANTICAVITY FLUORIDE RINSE
LISTERINE®
SMART RiNSE®
SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION
ALCOHOL FREE

*Versus brushing alone,
In a lab study.
IMPORTANT: Read
directions for proper use.

ADA
Accepted
American
Dental
Association®

BERRY
SLASH
500 mL (16.9 fl oz)

INGREDIENTS AND APPEARANCE

LISTERINE SMART RINSE BERRY SPLASH 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0606
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: 69968-0606-5	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/06/2020
2	NDC: 69968-0606-3	27 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/06/2020

Labeler - Johnson & Johnson Consumer Inc. (002347102)