LISTERINE ULTRACLEAN ANTISEPTIC  ARCTIC MINT- 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
Arctic Mint

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 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, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, flavor, sodium saccharin, FD&C blue no. 1

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE®
ULTRACLEAN®
WITH EVERFRESH™ TECHNOLOGY

ANTISEPTIC

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

* vs. brushing alone

ARCTIC MINT®

500 mL (1.05 Pt)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
LISTERINE ULTRACLEAN ANTISEPTIC   ARCTIC MINT
eucalyptol, menthol, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-448
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)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-448-9595 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/201204/28/2020
2NDC:42002-448-73250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/201204/29/2020
3NDC:42002-448-72500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/201204/28/2020
4NDC:42002-448-711000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/201204/29/2020
5NDC:42002-448-701500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/201204/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/03/201204/29/2020
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2020
Document Id: 3967c400-dbcb-49d1-a4d9-3767569b6680
Set id: d38a273c-3833-4459-9e80-c2b0c779772e
Version: 4
Effective Time: 20200911
 
Johnson & Johnson Consumer Inc.