listerine ®

listerine ®
SPL v4
SPL
SPL Set ID ee9a962d-83c7-4b13-bff6-140e48785e8a
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
sorbitol water phosphoric acid cetylpyridinium chloride sucralose saccharin sodium sodium phosphate, dibasic, anhydrous d&c red no. 33 fd&c green no. 3

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-01-01

Purpose

Anticavity

Description

Drug Facts


Medication Information

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
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

Description

Drug Facts

Questions?

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

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.

Active Ingredient

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

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.


Structured Label Content

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
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 33, Green 3

Questions?

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

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.

Active Ingredient (Active ingredient)

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

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

BERRY



SPLASH

500 mL (16.9Fl Oz)



IMPORTANT: Read



directions for proper use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)