Listerine Ultraclean AntisepticFresh Citrus

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]

LISTERINE ULTRACLEAN ANTISEPTIC  FRESH 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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Listerine Ultraclean Antiseptic
Fresh Citrus

Drug Facts

Active ingredientsPurposes
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%Antiplaque/antigingivitis
Thymol 0.064%

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 controlled room temperature 20° - 25° C (68° – 77° F)
  • cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive ingredients

water, alcohol (21.6%), sorbitol solution, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, yellow no. 6, red no. 40

Questions?

call toll-free 1-888-222-0182 or 215-273-8755 (collect)

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE®
ULTRACLEAN™
WITH EVERFRESH™ TECHNOLOGY

ANTISEPTIC

Controls Tartar Build-up
Kills Plaque 7 Gingivitis
Germs, Keeps Breath
Fresh for Hours

* vs. brushing alone                          FRESH CITRUS

500 mL (1.05 Pt)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
LISTERINE ULTRACLEAN ANTISEPTIC   FRESH CITRUS
eucalyptol, menthol, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42002-449
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)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sucralose (UNII: 96K6UQ3ZD4)  
FD&C Yellow No. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42002-449-72500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/201203/26/2020
2NDC: 42002-449-711000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/201203/26/2020
3NDC: 42002-449-701500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/201203/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/10/201203/26/2020
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 12/2018
Document Id: b4ac2390-f8d6-4f46-b2aa-6e6a66319c1a
Set id: c38eb3ba-2ad6-4ed0-b98d-493b2f7b1a61
Version: 3
Effective Time: 20181205
 
Johnson & Johnson Consumer Inc.