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

Listerine

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 20 mL (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 (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 - 1.5 L Bottle Label

ANTISEPTIC

LISTERINE ®

COOL MINT®

FOR A FRESHER &

CLEANER MOUTH THAN

BRUSHING ALONE

ADA

Accepted

American

Dental

Association ®

1.5L (1 Qt 1 Pt 2.7 fl oz)

Listerine_001

LISTERINE COOL MINT ANTISEPTIC
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0550
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)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69968-0550-9	95 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/03/2018
2	NDC:69968-0550-2	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/03/2018
3	NDC:69968-0550-5	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/03/2018
4	NDC:69968-0550-1	946.353 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/03/2018
5	NDC:69968-0550-4	1419.529 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/03/2018
6	NDC:69968-0550-3	3700 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019
7	NDC:69968-0550-8	2 in 1 PACKAGE	11/24/2020
7	NDC:69968-0550-4	1419.529 mL in 1 BOTTLE; 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	12/03/2018

Labeler - Johnson & Johnson Consumer Inc. (118772437)

Listerine Cool Mint Antiseptic