LISTERINE FRESHBURST ANTISEPTIC- eucalyptol, menthol, methyl salicylate, and thymol mouthwash 
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Listerine FreshBurst Antiseptic

Drug Facts

Active ingredientsPurposes
Eucalyptol 0.092% }
Menthol 0.042% }
Methyl salicylate 0.060% }
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%), sorbitol solution, flavoring, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, D&C yellow no. 10, FD&C green no. 3

Questions?

call 1-888-222-0182, weekdays

Dist: Johnson & Johnson Healthcare Products
Division of McNEIL-PPC, Inc.
Skillman, NJ 08558-9418 USA

PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label

LISTERINE®
FRESHBURST®
ANTISEPTIC

Kills Germs that Cause
Bad Breath, Plaque & the
Gum Disease Gingivitis

ADA
Accepted
American
Dental Association®

1.0L (1 Qt. 1.8 Fl Oz)

PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label
LISTERINE FRESHBURST ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-403
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Eucalyptol (UNII: RV6J6604TK) (Eucalyptol - UNII:RV6J6604TK) Eucalyptol0.92 mg  in 1 mL
Menthol, unspecified form (UNII: L7T10EIP3A) (Menthol, unspecified form - UNII:L7T10EIP3A) Menthol, unspecified form0.42 mg  in 1 mL
Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl Salicylate0.6 mg  in 1 mL
Thymol (UNII: 3J50XA376E) (Thymol - UNII:3J50XA376E) Thymol0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-403-73250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201205/24/2020
2NDC:42002-403-72500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201206/08/2020
3NDC:42002-403-711000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201202/10/2021
4NDC:42002-403-701500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201207/16/2020
5NDC:42002-403-633700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201202/10/2021
6NDC:42002-403-942 in 1 PACKAGE02/21/201208/19/2020
6NDC:42002-403-701500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35602/21/201202/10/2021
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2020
Document Id: f7366cdc-4f1f-46cc-a93c-4493577ceb55
Set id: 2cc4a86d-f081-434c-9703-606e9f778dda
Version: 5
Effective Time: 20200909
 
Johnson & Johnson Consumer Inc.