Listerine Smart Rinse Anticavity Rinse - Frozen

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2020-05-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:31:15

Label at a glance#

ProductListerine Smart Rinse Anticavity Rinse - Frozen Bubble Blast
Active ingredientsodium fluoride
Label structure11 sections

Dosage and administration

Adults and children 6 years of age and older: use twice daily 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. Pour in a cup. vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse replace cap promptly after use do not eat or drink for...

Storage and handling

store at room temperature do not use if printed band around cap is broken or missing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years of age and older:
    • use twice daily 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. Pour in a cup.
    • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
    • do not swallow the rinse
    • replace cap promptly after use
    • 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

STORAGE AND HANDLING SECTION

  • store at room temperature
  • do not use if printed band around cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, flavor, phosphoric acid, sucralose, cetylpyridinium chloride, disodium phosphate, sodium saccharin, menthol, blue 1, green 3

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LISTERINE®

SMART RINSE®

ANTICAVITY
FLUORIDE RINSE

Disney
FROZEN
As seen in
FROZEN
FEVER

Helps Prevent Cavities

Removes Particles
Brushing May Miss

BUBBLE BLAST

IMPORTANT: Read
directions for proper use.

ADA
ACCEPTED
American
Dental
Association®

BUBBLE
BLAST®

500 mL (16.9 fl oz)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-027669968-0276-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ebd75d0e-b483-1fd0-e053-2995a90a85fb1d61338e-3654-4d1b-8dbb-d7b6dfd114aa2022-10-25WarningsExact identifier
spl set id: 1d61338e-3654-4d1b-8dbb-d7b6dfd114aa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.