Listerine Ultraclean Fresh Citrus: Package Insert and Label Information

LISTERINE ULTRACLEAN FRESH CITRUS- eucalyptol, menthol, unspecified form, 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.

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, Poloxamer 407, Flavor, Benzoic Acid, Zinc Chloride, Sodium Benzoate, Sucralose, Yellow 6, Red 40

Questions ?

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

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL — 1.5 L Bottle Label

ANTISEPTIC
LISTERINE ®
ULTRACLEAN

FOR UP TO A 3X
LONGER LASTING
CLEAN FEELING*

*vs. brushing alone

FRESH CITRUS

1.5L (1 Qt 1 Pt 2.7 Fl Oz)

PRINCIPAL DISPLAY PANEL -- 1.5 L Bottle Label
(click image for full-size original)
LISTERINE ULTRACLEAN FRESH CITRUS
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0398
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 0.92 mg in 1 mL
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 0.42 mg in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.6 mg in 1 mL
THYMOL (THYMOL) THYMOL 0.64 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BENZOATE
SUCRALOSE
FD&C YELLOW NO. 6
FD&C RED NO. 40
WATER
ALCOHOL
SORBITOL
POLOXAMER 407
BENZOIC ACID
ZINC CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69968-0398-1 1000 mL in 1 BOTTLE, PLASTIC None
2 NDC:69968-0398-2 1500 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 08/10/2012
Labeler — Johnson & Johnson Consumer Inc. (002347102)

Revised: 09/2021 Johnson & Johnson Consumer Inc.

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