LISTERINE ADVANCED WITH TARTAR PROTECTION ANTISEPTIC  CITRUS- 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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Advanced Listerine Antiseptic
With Tartar Protection
- Citrus -

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

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, zinc chloride, sucralose, sodium benzoate, FD&C yellow no. 6, FD&C red no. 40.

Questions?

call 1-888-222-0182, weekdays or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE®
ADVANCED
WITH TARTAR PROTECTION

ANTISEPTIC

Kills the Germs that Cause
Bad Breath, Plaque & Gingivitis
Plus Prevents Tartar for a
Cleaner Mouth**

Citrus

500 mL (1.05 Pt)

Principal Display Panel - 500 mL Bottle Label
LISTERINE ADVANCED WITH TARTAR PROTECTION ANTISEPTIC   CITRUS
eucalyptol, menthol, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-407
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)  
zinc chloride (UNII: 86Q357L16B)  
sucralose (UNII: 96K6UQ3ZD4)  
sodium benzoate (UNII: OJ245FE5EU)  
FD&C yellow no. 6 (UNII: H77VEI93A8)  
FD&C red no. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-407-9595 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/201310/01/2015
2NDC:42002-407-73250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/201310/01/2015
3NDC:42002-407-72500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/201310/01/2015
4NDC:42002-407-711000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/201310/01/2015
5NDC:42002-407-701500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/201310/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35610/11/201310/01/2015
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 6/2016
Document Id: 24d316c1-cbfd-46dd-ba65-05768b053c0e
Set id: 595ab98f-04a1-4a9a-baf4-868846034b06
Version: 2
Effective Time: 20160628
 
Johnson & Johnson Consumer Inc.