LISTERINE ULTRACLEAN ANTISEPTIC  COOL MINT- eucalyptol, menthol, methyl salicylate, and thymol mouthwash 
Johnson & Johnson Consumer 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
Cool Mint

Drug Facts

Active ingredients

Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%

Purposes

Antiplaque/antigingivitis

Uses

helps prevent and reduce:

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

Other information

Inactive ingredients

water, alcohol (21.6%), sorbitol solution, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, sodium saccharin, green no. 3

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

*vs. brushing alone

COOL MINT®

500 mL (1.05 Pt)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
LISTERINE ULTRACLEAN ANTISEPTIC   COOL MINT
eucalyptol, menthol, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-447
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Eucalyptol (UNII: RV6J6604TK) (Eucalyptol - UNII:RV6J6604TK) Eucalyptol0.92 mg  in 1 mL
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form0.42 mg  in 1 mL
Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl Salicylate0.6 mg  in 1 mL
Thymol (UNII: 3J50XA376E) (Thymol - UNII:3J50XA376E) Thymol0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Sorbitol (UNII: 506T60A25R)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Zinc Chloride (UNII: 86Q357L16B)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sucralose (UNII: 96K6UQ3ZD4)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
FD&C Green No. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-447-9595 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/201212/01/2023
2NDC:42002-447-73250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/201212/01/2023
3NDC:42002-447-72500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/201212/01/2023
4NDC:42002-447-711000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/201212/01/2023
5NDC:42002-447-701500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/201212/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/09/201212/01/2023
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 1/2019
Document Id: 2911671d-5ba1-40c5-8ea2-a1027651b58f
Set id: 2c9b9404-fbcd-4d8a-afe3-3980bf33ac4e
Version: 2
Effective Time: 20190107
 
Johnson & Johnson Consumer Inc.