LISTERINE ORIGINAL 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 ® ORIGINAL ANTISEPTIC

Drug Facts

Active ingredientPurpose
Eucalyptol (0.092%)Antiplaque/antigingivitis
Menthol (0.042%)Antiplaque/antigingivitis
Methyl Salicylate (0.060%)Antiplaque/antigingivitis
Thymol (0.064%)Antiplaque/antigingivitis

Use

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 (26.9% v/v), benzoic acid, poloxamer 407, sodium benzoate, caramel

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 1.5 L Bottle Label

ANTISEPTIC
LISTERINE ®
ORIGINAL

FOR A FRESHER &
CLEANER MOUTH THAN
BRUSHING ALONE

ADA
Accepted
American
Dental
Association ®

1.5 L (1 Qt 1 Pt 2.7 Fl Oz)

PRINCIPAL DISPLAY PANEL - 1.5 L Bottle Label
LISTERINE  ORIGINAL ANTISEPTIC
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0400
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)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARAMEL (UNII: T9D99G2B1R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0400-2250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/06/2019
2NDC:69968-0400-5500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/06/2019
3NDC:69968-0400-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/06/2019
4NDC:69968-0400-11500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/06/2019
5NDC:69968-0400-995 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/06/2019
6NDC:69968-0400-82 in 1 PACKAGE01/06/2019
6NDC:69968-0400-11500 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 finalpart35601/06/2019
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2021
Document Id: cb1580ce-f539-4900-e053-2a95a90a8012
Set id: 78e2e172-09a4-4bf1-9871-d099c49087be
Version: 4
Effective Time: 20210903
 
Johnson & Johnson Consumer Inc.