LISTERINE ULTRACLEAN ANTISEPTIC ARCTIC MINT- eucalyptol, menthol, methyl salicylate, and thymol mouthwash

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]

SPL UNCLASSIFIED SECTION

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)

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

LISTERINE ULTRACLEAN ANTISEPTIC   ARCTIC MINT
eucalyptol, menthol, methyl salicylate, and thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42002-448
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Eucalyptol (UNII: RV6J6604TK) (Eucalyptol - UNII:RV6J6604TK)	Eucalyptol	0.92 mg  in 1 mL
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	0.42 mg  in 1 mL
Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ)	Methyl Salicylate	0.6 mg  in 1 mL
Thymol (UNII: 3J50XA376E) (Thymol - UNII:3J50XA376E)	Thymol	0.64 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42002-448-95	95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/03/2012
2	NDC: 42002-448-73	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/03/2012
3	NDC: 42002-448-72	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/03/2012
4	NDC: 42002-448-71	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/03/2012
5	NDC: 42002-448-70	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/03/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	07/03/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)