LISTERINE FRESHBURST ANTISEPTIC- eucalyptol, menthol, unspecified form, methyl salicylate, and 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

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

• 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 - 1.5 L Bottle Label

ANTISEPTIC
LISTERINE®
FRESHBURST®
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, unspecified form, methyl salicylate, and thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0239
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: 69968-0239-5	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/17/2018
2	NDC: 69968-0239-2	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/03/2019
3	NDC: 69968-0239-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/18/2018
4	NDC: 69968-0239-3	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	08/17/2018

Labeler - Johnson & Johnson Consumer Inc. (002347102)