LISTERINE NATURALS ENAMEL REPAIR ANTICAVITY FLUORIDE, HERBAL MINT- sodium fluoride mouthwash

LISTERINE NATURALS Enamel Repair Anticavity Fluoride, Herbal Mint by

Drug Labeling and Warnings

LISTERINE NATURALS Enamel Repair Anticavity Fluoride, Herbal Mint by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Sodium Fluoride 0.02% (0.01% w/v Fluoride Ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

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 12 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
  • Supervise children as necessary until capable of using without supervision
• Children under 12 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, Methyl Salicylate, Thymol, Stevia Rebaudiana Leaf Extract, Phosphoric Acid, Menthol, Flavor, Disodium Phosphate

Questions?

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

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Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE ®

NATURALS

IMPORTANT: READ DIRECTIONS FOR PROPER USE.             SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

ANTICAVITY FLUORIDE MOUTHWASH

ENAMEL REPAIR

HELPS RESTORE ENAMEL & KILLS
99.9% OF BAD BREATH GERMS

HERBAL MINT

500mL (1.05 Pt)

INGREDIENTS AND APPEARANCE

LISTERINE NATURALS ENAMEL REPAIR ANTICAVITY FLUORIDE, HERBAL MINT 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0697
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
THYMOL (UNII: 3J50XA376E)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
PHOSPHORIC ACID (UNII: E4GA8884NN)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0697-5	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/04/2021

Labeler - Johnson & Johnson Consumer Inc. (118772437)