LISTERINE COOL MINT ANTISEPTIC- eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash

Listerine Cool Mint Antiseptic by

Drug Labeling and Warnings

Listerine Cool Mint 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 room temperature
• cold water may cloud this product. Its antiseptic properties are not affected.

Inactive ingredients

Water, Alcohol (21.6%), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Flavor, Green 3

Questions or comments?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 3.7 LITER Bottle Label

ANTISEPTIC
LISTERINE®
COOL MINT®

KILLS 99.9% OF GERMS THAT CAUSE BAD BREATH, PLAQUE & GINGIVITIS
FOR A FRESHER & CLEANER MOUTH THAN BRUSHING ALONE
ADA
Accepted
American
Dental
Association®

• Helps prevent and
  reduce plaque
• Helps prevent and
  reduce gingivitis

3.7 LITERS (1 Gallon)
PROFESSIONAL SIZE FOR USE
BY DENTISTS AND DENTAL HYGIENISTS

INGREDIENTS AND APPEARANCE

LISTERINE COOL MINT ANTISEPTIC 
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0477
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	0.60 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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Sodium Benzoate (UNII: OJ245FE5EU)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0477-7	95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2009
2	NDC: 69968-0477-6	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2009
3	NDC: 69968-0477-5	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2009
4	NDC: 69968-0477-4	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2009
5	NDC: 69968-0477-3	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2009
6	NDC: 69968-0477-1	3700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2009
7	NDC: 69968-0477-2	2 in 1 PACKAGE	06/01/2009
7	NDC: 69968-0477-3	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/01/2009

Labeler - Johnson & Johnson Consumer Inc. (002347102)