Drug Facts

Active ingredient	Purpose
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:

plaque
gingivitis

Warnings

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

rinse full strength for 30 seconds with 20mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night
do not swallow

Other information

this rinse is not intended to replace brushing or flossing
store at room temperature
cold weather may cloud this product. Its antiseptic properties are not affected.

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

ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

LISTERINE®

ORIGINAL

ANTISEPTIC

FOR A FRESHER &

CLEANER MOUTH THAN

BRUSHING ALONE

ADA

Accepted

American

Dental

Association ®

1.5 L (1 Qt 1 Pt 2.7 Fl Oz)

Listerine_01

LISTERINE ORIGINAL ANTISEPTIC
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0400
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.42 mg in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.6 mg in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0400-2	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/06/2019	09/02/2023
2	NDC:69968-0400-5	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/06/2019	10/01/2023
3	NDC:69968-0400-3	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/06/2019
4	NDC:69968-0400-1	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/06/2019
5	NDC:69968-0400-9	95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/06/2019	10/07/2021
6	NDC:69968-0400-8	2 in 1 PACKAGE	01/06/2019
6	NDC:69968-0400-1	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	01/06/2019

Labeler - Johnson & Johnson Consumer Inc. (118772437)