LISTERINE COOL MINT ANTISEPTIC- 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 Cool Mint 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, 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 - 1.0 L Bottle Label

LISTERINE®
COOL MINT®
ANTISEPTIC

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

ADA
Accepted
American
Dental
Association®

1.0L (1 Qt. 1.8 Fl Oz)

PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label
LISTERINE COOL MINT ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-402
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)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sodium Benzoate (UNII: OJ245FE5EU)  
FD&C Green No. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-402-9595 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201212/27/2020
2NDC:42002-402-73250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201212/27/2020
3NDC:42002-402-72500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201212/08/2020
4NDC:42002-402-711000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201212/29/2020
5NDC:42002-402-701500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201212/27/2020
6NDC:42002-402-633700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201201/31/2021
7NDC:42002-402-942 in 1 PACKAGE02/21/201202/01/2021
7NDC:42002-402-701500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35602/21/201202/01/2021
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2020
Document Id: f853b4dd-dcfb-44fb-a5f7-b12432c2d404
Set id: 9d10eb10-568f-4863-9948-4ed990fbb474
Version: 4
Effective Time: 20200925
 
Johnson & Johnson Consumer Inc.