LISTERINE COOL MINT ANTISEPTIC- eucalyptol, menthol, unspecified form, methyl salicylate, and thymol liquid 
Navajo Manufacturing Company 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:

Warnings

Listerine 95 mL

Do not use in children under 12 years of age

Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use.

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, 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)

PRINCIPAL DISPLAY PANEL

Listerine

LISTERINE COOL MINT ANTISEPTIC 
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-216(NDC:69968-0550)
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:67751-216-011 in 1 BLISTER PACK03/02/2023
195 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/03/2018
Labeler - Navajo Manufacturing Company Inc. (091917799)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc.136941411relabel(67751-216) , repack(67751-216)

Revised: 3/2023
Document Id: f5f252db-7fce-0455-e053-2a95a90ae255
Set id: f5f26e2f-8a1f-4687-e053-2a95a90ae378
Version: 1
Effective Time: 20230302
 
Navajo Manufacturing Company Inc.