Listerine ®

Listerine ®
SPL v5
SPL
SPL Set ID 773255d9-aa0c-435e-a1e5-0b9332793831
Route
ORAL
Published
Effective Date 2024-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Sorbitol Phosphoric Acid Cetylpyridinium Chloride Sucralose Saccharin Sodium Sodium Phosphate, Dibasic, Anhydrous Fd&c Red No. 40 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-01-01 Until 2026-09-17

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

Aids in the prevention of dental cavities

Section 42229-5

Drug Facts

Section 50565-1

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
Questions?

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

Active Ingredient

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

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 40, Red 33

Principal Display Panel 500 Ml Bottle Label

2X STRONGER TEETH FOR



BETTER CAVITY PROTECTION*




*with a brushing, in a lab study



ALCOHOL FREE

ANTICAVITY FLUORIDE RINSE



LISTERINE ®

SMART RiNSE ®



SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION

PINK



LEMONADE



FLAVOR

500 mL (16.9Fl Oz)

IMPORTANT: Read



directions for proper use.


Structured Label Content

Use

Aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Purpose

Anticavity

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
Questions?

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

Active Ingredient (Active ingredient)

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

Other Information (Other information)
  • Store at room temperature
  • Cold weather may temporarily cloud this product
Inactive Ingredients (Inactive ingredients)

Water, Sorbitol, Flavor, Phosphoric Acid, Cetylpyridinium Chloride, Sucralose, Sodium Saccharin, Disodium Phosphate, Red 40, Red 33

Principal Display Panel 500 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label)

2X STRONGER TEETH FOR



BETTER CAVITY PROTECTION*




*with a brushing, in a lab study



ALCOHOL FREE

ANTICAVITY FLUORIDE RINSE



LISTERINE ®

SMART RiNSE ®



SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION

PINK



LEMONADE



FLAVOR

500 mL (16.9Fl Oz)

IMPORTANT: Read



directions for proper use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)