LISTERINE FRESHBURST ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Listerine Freshburst Antiseptic by

Drug Labeling and Warnings

Listerine Freshburst 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

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, Sodium Saccharin, Flavor, Sodium Benzoate, Yellow 10, Green 3

Questions?

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

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 1500 mL Bottle Label

ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

LISTERINE ®

FRESHBURST ®

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)

INGREDIENTS AND APPEARANCE

LISTERINE FRESHBURST ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0792
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0792-5	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2023
2	NDC: 69968-0792-3	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2023
3	NDC: 69968-0792-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2023
4	NDC: 69968-0792-2	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	04/21/2023

Labeler - Kenvue Brands LLC (118772437)