listerine ®

listerine ®
SPL v7
SPL
SPL Set ID b2ce66c3-dc48-47a5-a731-5550bc194679
Route
oral
Published
Effective Date 2020-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.1 mg)
Inactive Ingredients
water alcohol sorbitol poloxamer 407 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 active Since 2009-11-01 Until 2023-08-28

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
    • 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, Alcohol (21.6% v/v), Sorbitol, Poloxamer 407, Eucalyptol, Flavor, Methyl Salicylate, Menthol, Phosphoric Acid, Sodium Saccharin, Thymol, 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 500 Ml Bottle Label

ANTICAVITY FLOURIDE MOUTHWASH

LISTERINE ®

TOTAL CARE

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

SODIUM FLUORIDE &

ACIDULATED PHOSPHATE TOPICAL SOLUTION

6 IN 1

BENEFITS

  • HELPS PREVENT CAVITIES
  • RESTORES ENAMEL
  • STRENGTHENS TEETH
  • KILLS BAD BREATH GERMS
  • CLEANS THE WHOLE MOUTH
  • FRESHENS BREATH

500 mL (16.9 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
    • 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, Alcohol (21.6% v/v), Sorbitol, Poloxamer 407, Eucalyptol, Flavor, Methyl Salicylate, Menthol, Phosphoric Acid, Sodium Saccharin, Thymol, 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 500 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label)

ANTICAVITY FLOURIDE MOUTHWASH

LISTERINE ®

TOTAL CARE

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

SODIUM FLUORIDE &

ACIDULATED PHOSPHATE TOPICAL SOLUTION

6 IN 1

BENEFITS

  • HELPS PREVENT CAVITIES
  • RESTORES ENAMEL
  • STRENGTHENS TEETH
  • KILLS BAD BREATH GERMS
  • CLEANS THE WHOLE MOUTH
  • FRESHENS BREATH

500 mL (16.9 Fl Oz) FRESH MINT


Advanced Ingredient Data


Raw Label Data

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