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Listerine FreshBurst Antiseptic

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: 42002-403

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 FreshBurst Antiseptic

Drug Facts

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

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 room temperature
  • cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive ingredients

water, alcohol (21.6%), sorbitol solution, flavoring, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, D&C yellow no. 10, FD&C green no. 3

Questions?

call 1-888-222-0182, weekdays

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE®
FRESHBURST®
ANTISEPTIC

Kills Germs that Cause
Bad Breath, Plaque & the
Gum Disease Gingivitis

ADA
Accepted
American
Dental Association®

500 mL (1.05 Pt)

LISTERINE FRESHBURST ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-403
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 (Methyl Salicylate) 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 
Saccharin Sodium Dihydrate 
Sodium Benzoate 
D&C Yellow No. 10 
FD&C Green No. 3 
Packaging
#Item CodePackage Description
1NDC:42002-403-73250 mL in 1 BOTTLE, PLASTIC
2NDC:42002-403-72500 mL in 1 BOTTLE, PLASTIC
3NDC:42002-403-711000 mL in 1 BOTTLE, PLASTIC
4NDC:42002-403-701500 mL in 1 BOTTLE, PLASTIC
5NDC:42002-403-633700 mL in 1 BOTTLE, PLASTIC
6NDC:42002-403-942 BOTTLE, PLASTIC (BOTTLE) in 1 PACKAGE
6NDC:42002-403-701500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35602/21/2012
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 02/2012
Document Id: f0c6b346-44e1-4823-bc15-9e09a071467a
Set id: 2cc4a86d-f081-434c-9703-606e9f778dda
Version: 1
Effective Time: 20120222
 
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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