LISTERINE ULTRACLEAN ANTISEPTIC COOL MINT- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Listerine Ultraclean Antiseptic by

Drug Labeling and Warnings

Listerine Ultraclean Antiseptic by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Uses

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 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% v/v), Sorbitol, Poloxamer 407, Benzoic Acid, Zinc Chloride, Flavor, Sodium Benzoate, Sucralose, Sodium Saccharin, Green 3

Questions?

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

SPL UNCLASSIFIED SECTION

Distributed by:
KENVUE BRANDS LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ANTISEPTIC

LISTERINE ®

ULTRACLEAN ®

ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

4 IN 1

BENEFITS

1. HELPS REDUCE & PREVENT HARD

TO REMOVE BUILDUP (tartar)

2. LONGER LASTING CLEAN †
3. FIGHTS PLAQUE & GINGIVITIS
4. KILLS 99.9% OF GERMS *

†vs. brushing alone *bad breath germs

COOL MINT ®

500 mL (1.05 Pt)

INGREDIENTS AND APPEARANCE

LISTERINE ULTRACLEAN ANTISEPTIC  COOL MINT
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0788
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg  in 1 mL
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ZINC CHLORIDE (UNII: 86Q357L16B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0788-5	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/05/2023
2	NDC: 69968-0788-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/05/2023
3	NDC: 69968-0788-2	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/05/2023
4	NDC: 69968-0788-9	2 in 1 PACKAGE	02/05/2023
4		1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	02/05/2023

Labeler - Kenvue Brands LLC (118772437)