LISTERINE ULTRACLEAN ANTISEPTIC  ARTIC MINT- eucalyptol, menthol, methyl salicylate and thymol mouthwash 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

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.

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Listerine Ultraclean Antiseptic
Arctic Mint

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 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, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, flavor, sodium saccharin, blue no. 1

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 & Gingivitis
Germs, Keeps Breath
Fresh for Hours

8 vs. brushing along

ARTIC MINT®

500 mL (1.05 Pt)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
LISTERINE ULTRACLEAN ANTISEPTIC   ARTIC MINT
eucalyptol, menthol, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42002-448
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 
Zinc Chloride 
Sodium Benzoate 
Sucralose 
Saccharin Sodium Dihydrate 
Fd&C Blue No. 1 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-448-9595 mL in 1 BOTTLE, PLASTIC
2NDC:42002-448-73250 mL in 1 BOTTLE, PLASTIC
3NDC:42002-448-72500 mL in 1 BOTTLE, PLASTIC
4NDC:42002-448-711000 mL in 1 BOTTLE, PLASTIC
5NDC:42002-448-701500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/03/2012
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 7/2012
Document Id: 8538225b-cbf7-4947-9eac-bafba8dd1620
Set id: d38a273c-3833-4459-9e80-c2b0c779772e
Version: 1
Effective Time: 20120706
 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.