LISTERINE COOL MINT ANTISEPTIC- eucalyptol, menthol, unspecified form, 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 ingredients

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

Purposes

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 water may cloud this product. Its antiseptic properties are not affected.

Inactive ingredients

Water, Alcohol (21.6%), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Flavor, Green 3

Questions or comments?

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

Distributed by:
JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 3.7 LITER Bottle Label

ANTISEPTIC
LISTERINE®
COOL MINT®

KILLS 99.9% OF GERMS THAT CAUSE BAD BREATH, PLAQUE & GINGIVITIS
FOR A FRESHER & CLEANER MOUTH THAN BRUSHING ALONE
ADA
Accepted

American
Dental
Association®

  • Helps prevent and
    reduce plaque
  • Helps prevent and
    reduce gingivitis

3.7 LITERS (1 Gallon)
PROFESSIONAL SIZE FOR USE
BY DENTISTS AND DENTAL HYGIENISTS

PRINCIPAL DISPLAY PANEL - 3.7 LITER Bottle Label
LISTERINE COOL MINT ANTISEPTIC 
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0477
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 Salicylate0.60 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:69968-0477-795 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/200912/27/2020
2NDC:69968-0477-6250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/200912/27/2020
3NDC:69968-0477-5500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/200912/08/2020
4NDC:69968-0477-41000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/200912/29/2020
5NDC:69968-0477-31500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/200912/27/2020
6NDC:69968-0477-13700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/200901/31/2021
7NDC:69968-0477-22 in 1 PACKAGE06/01/200902/01/2021
7NDC:69968-0477-31500 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 finalpart35606/01/200902/01/2021
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2020
 
Johnson & Johnson Consumer Inc.