listerine ®

listerine ®
SPL v5
SPL
SPL Set ID 90b5c3d8-baa4-44ab-8f73-e177007f0219
Route
oral
Published
Effective Date 2025-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.3 mg)
Inactive Ingredients
water sorbitol hydrated silica glycerin polyethylene glycol 1600 sodium lauryl sulfate carboxymethylcellulose sodium, unspecified saccharin sodium eucalyptol methyl salicylate thymol phosphoric acid menthol, unspecified form sodium phosphate xanthan gum benzoic acid spearmint oil sodium phosphate, dibasic, anhydrous fd&c blue no. 1 d&c yellow no. 10

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-03-03

Purpose

Anticavity

Description

Drug Facts


Medication Information

Purpose

Anticavity

Directions
  • adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician.
    • children 2-6 years use a pea sized amount
    • instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision.
  • children under 2 years of age: ask a dentist or doctor
Other Information
  • Store at Room Temperature.
Inactive Ingredients

water, sorbitol, hydrated silica, glycerin, PEG-32, sodium lauryl sulfate, cellulose gum, sodium saccharin, eucalyptol, methyl salicylate, thymol, phosphoric acid, menthol, sodium phosphate, xanthan gum, benzoic acid, flavor, mentha viridis (spearmint) leaf oil, disodium phosphate, blue 1, yellow 10

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 under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Principal Display Panel 119 G Tube Carton

LISTERINE ®



ESSENTIAL CARE ®




FLUORIDE ANTICAVITY TOOTHPASTE



ORIGINAL GEL

  • FRESHENS BREATH
  • THE LISTERINE ® WAY

POWERFULL MINT GEL



Kills the Germs



that Cause Bad Breath



Helps Prevent Cavities



Removes Stains




NET WT. 4.2 OZ. (119 g)


Structured Label Content

Purpose

Anticavity

Directions
  • adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician.
    • children 2-6 years use a pea sized amount
    • instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision.
  • children under 2 years of age: ask a dentist or doctor
Other Information (Other information)
  • Store at Room Temperature.
Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, glycerin, PEG-32, sodium lauryl sulfate, cellulose gum, sodium saccharin, eucalyptol, methyl salicylate, thymol, phosphoric acid, menthol, sodium phosphate, xanthan gum, benzoic acid, flavor, mentha viridis (spearmint) leaf oil, disodium phosphate, blue 1, yellow 10

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 under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Principal Display Panel 119 G Tube Carton (PRINCIPAL DISPLAY PANEL - 119 g Tube Carton)

LISTERINE ®



ESSENTIAL CARE ®




FLUORIDE ANTICAVITY TOOTHPASTE



ORIGINAL GEL

  • FRESHENS BREATH
  • THE LISTERINE ® WAY

POWERFULL MINT GEL



Kills the Germs



that Cause Bad Breath



Helps Prevent Cavities



Removes Stains




NET WT. 4.2 OZ. (119 g)


Advanced Ingredient Data


Raw Label Data

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