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Listerine Ultraclean Antiseptic Fresh Citrus

Dosage form: mouthwash
Ingredients: Eucalyptol 0.92mg in 1mL, Menthol 0.42mg in 1mL, Methyl Salicylate 0.6mg in 1mL, Thymol 0.64mg in 1mL
Labeler: Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.
NDC Code: 42002-449

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Listerine Ultraclean Antiseptic
Fresh Citrus

Drug Facts

Active ingredientsPurposes
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%Antiplaque/antigingivitis
Thymol 0.064%

Uses

helps prevent and reduce:

  • plaque
  • gingivitis

Warnings

Do not use in children under 12 years of age

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
  • rinse full strength for 30 seconds with 20 ml (2/3 fluid ounce or 4 teaspoonfuls) morning and night
  • do not swallow

Other information
  • store at controlled room temperature 20° - 25° C (68° – 77° F)
  • cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive ingredients

water, alcohol (21.6%), sorbitol solution, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, yellow no. 6, red no. 40

Questions?

call toll-free 1-888-222-0182 or 215-273-8755 (collect)

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE®
ULTRACLEAN™
WITH EVERFRESH™ TECHNOLOGY

ANTISEPTIC

Controls Tartar Build-up
Kills Plaque 7 Gingivitis
Germs, Keeps Breath
Fresh for Hours

* vs. brushing alone                          FRESH CITRUS

500 mL (1.05 Pt)

LISTERINE ULTRACLEAN ANTISEPTIC   FRESH CITRUS
eucalyptol, menthol, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-449
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Eucalyptol (Eucalyptol) Eucalyptol0.92 mg  in 1 mL
Menthol (Menthol) Menthol0.42 mg  in 1 mL
Methyl Salicylate (Salicylic Acid) Methyl Salicylate0.6 mg  in 1 mL
Thymol (Thymol) Thymol0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Alcohol 
Sorbitol 
Poloxamer 407 
Benzoic Acid 
Zinc Chloride 
Sodium Benzoate 
Sucralose 
FD&C Yellow No. 6 
FD&C RED NO. 40 
Packaging
#Item CodePackage Description
1NDC:42002-449-72500 mL in 1 BOTTLE, PLASTIC
2NDC:42002-449-711000 mL in 1 BOTTLE, PLASTIC
3NDC:42002-449-701500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35607/10/2012
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 07/2012
Document Id: 3b9f950e-31cf-4acc-8275-d96ee100a7ef
Set id: c38eb3ba-2ad6-4ed0-b98d-493b2f7b1a61
Version: 1
Effective Time: 20120712
 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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