Listerine ®

Listerine ®
SPL v4
SPL
SPL Set ID d69d2e0d-a3e3-4d95-992d-c0c59172b3a5
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 Sucralose Phosphoric Acid Cetylpyridinium Chloride Menthol, Unspecified Form Sodium Phosphate, Dibasic, Anhydrous Fd&c Yellow No. 6 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-01

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, Sucralose, Phosphoric Acid, Cetylpyridinium Chloride, Menthol, Disodium Phosphate, Flavor, Yellow 6, Blue 1

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

MINT



SHEILD

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, Sucralose, Phosphoric Acid, Cetylpyridinium Chloride, Menthol, Disodium Phosphate, Flavor, Yellow 6, Blue 1

Principal Display Panel 500 Ml Bottle Label (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

MINT



SHEILD

500 mL (16.9Fl Oz)

IMPORTANT: Read



directions for proper use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)