LISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE AVENGERS- sodium fluoride mouthwash

Listerine SmartRinse Anticavity Fluoride Rinse by

Drug Labeling and Warnings

Listerine SmartRinse Anticavity Fluoride Rinse 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 6 years of age and older:
  • use twice a daily after brushing your teeth with a toothpaste
  • remove cap and hold bottle upright. Fill to10 mL line by squeezing the front and back (not the sides) of the bottle. Stop squeezing. Excess liquid will drain back into the bottle. Pour in a cup.
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • replace cap promptly after use
  • 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
• do not use if printed band around cap is broken or missing

Inactive ingredients

water, sorbitol, sucralose, phosphoric acid, cetylpyridinium chloride, menthol, disodium phosphate, flavor, yellow 6, blue 1

Questions?

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

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Distributed by:
Johnson & Johnson Healthcare Products
Division of McNEIL-PPC, Inc. Skillman, NJ 08558-9418 USA

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE®
SMART RINSE®
ANTICAVITY
FLUORIDE RINSE

MARVEL
AVENGERS

Helps Prevent Cavities
Removes Particles
Brushing May Miss

IMPORTANT; Read
Directions for proper use.

ADA
Accepted
American
Dental Association®

MINT
SHIELD®

500 mL (16.9 fl oz)

INGREDIENTS AND APPEARANCE

LISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE   AVENGERS
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42002-618
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Sucralose (UNII: 96K6UQ3ZD4)
Phosphoric Acid (UNII: E4GA8884NN)
Cetylpyridinium Chloride (UNII: D9OM4SK49P)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)
FD&C Yellow No. 6 (UNII: H77VEI93A8)
FD&C Blue No. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42002-618-72	500 mL in 1 BOTTLE, PLASTIC; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	05/12/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	05/12/2014

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Registrant - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)