listerine ®

listerine ®
SPL v7
SPL
SPL Set ID 4b594a6e-db1d-443b-bfa7-23ee15749f47
Route
oral
Published
Effective Date 2022-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.1 mg)
Inactive Ingredients
water sorbitol propylene glycol sodium lauryl sulfate poloxamer 407 sodium benzoate phosphoric acid eucalyptol thymol methyl salicylate saccharin sodium menthol, unspecified form sodium phosphate, dibasic, anhydrous sucralose fd&c red no. 40 fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2012-07-25 Until 2025-12-23

Purpose

Anticavity

Description

Drug Facts


Medication Information

Purpose

Anticavity

Directions
  • Adults and children 6 years of age and older:
    • use twice daily after brushing your teeth with a toothpaste
    • vigorously swish 10mL (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, Propylene Glycol, Poloxamer 407, Sodium Lauryl Sulfate, Flavor, Sodium Benzoate, Phosphoric Acid, Eucalyptol, Methyl Salicylate, Thymol, Sodium Saccharin, Menthol, Disodium Phosphate, Sucralose, Red 40, Blue 1

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 1000 Ml Bottle Label

ANTICAVITY FLUORIDE MOUTHWASH

LISTERINE®

TOTAL CARE

IMPORTANT: READ DIRECTIONS FOR PROPER USE

SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION

ZERO ALCOHOL

6 IN 1

BENEFITS

  • 24-HOUR CAVITY PROTECTION+
  • RESTORES ENAMEL
  • STRENGTHENS TEETH
  • FRESHENS BREATH
  • CLEANS WHOLE MOUTH
  • KILLS BAD BREATH GERMS

+when used twice daily *bad breath germs

1.0L (1 Qt 1.8 Fl Oz)

FRESH MINT


Structured Label Content

Purpose

Anticavity

Directions
  • Adults and children 6 years of age and older:
    • use twice daily after brushing your teeth with a toothpaste
    • vigorously swish 10mL (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, Propylene Glycol, Poloxamer 407, Sodium Lauryl Sulfate, Flavor, Sodium Benzoate, Phosphoric Acid, Eucalyptol, Methyl Salicylate, Thymol, Sodium Saccharin, Menthol, Disodium Phosphate, Sucralose, Red 40, Blue 1

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 1000 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label)

ANTICAVITY FLUORIDE MOUTHWASH

LISTERINE®

TOTAL CARE

IMPORTANT: READ DIRECTIONS FOR PROPER USE

SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION

ZERO ALCOHOL

6 IN 1

BENEFITS

  • 24-HOUR CAVITY PROTECTION+
  • RESTORES ENAMEL
  • STRENGTHENS TEETH
  • FRESHENS BREATH
  • CLEANS WHOLE MOUTH
  • KILLS BAD BREATH GERMS

+when used twice daily *bad breath germs

1.0L (1 Qt 1.8 Fl Oz)

FRESH MINT


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)