Listerine Cool Mint Antiseptic: Package Insert and Label Information

LISTERINE COOL MINT ANTISEPTIC- eucalyptol, menthol, unspecified form, methyl salicylate and thymol liquid
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, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Flavor, Green 3

Questions or Comments?

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 ®
COOL MINT ®

FOR A FRESHER &
CLEANER MOUTH THAN
BRUSHING ALONE

ADA Accepted
American
Dental
Association ®

30040704

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 COOL MINT ANTISEPTIC
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0550
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
WATER
ALCOHOL
SORBITOL
POLOXAMER 407
BENZOIC ACID
SACCHARIN SODIUM
SODIUM BENZOATE
FD&C GREEN NO. 3
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69968-0550-9 95 mL in 1 BOTTLE None
2 NDC:69968-0550-2 250 mL in 1 BOTTLE None
3 NDC:69968-0550-5 500 mL in 1 BOTTLE None
4 NDC:69968-0550-1 946.353 mL in 1 BOTTLE None
5 NDC:69968-0550-4 1419.529 mL in 1 BOTTLE None
6 NDC:69968-0550-3 3700 mL in 1 BOTTLE None
7 NDC:69968-0550-8 2 BOTTLE in 1 PACKAGE contains a BOTTLE (69968-0550-4)
7 NDC:69968-0550-4 1419.529 mL in 1 BOTTLE This package is contained within the PACKAGE (69968-0550-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 12/03/2018
Labeler — Johnson & Johnson Consumer Inc. (002347102)

Revised: 09/2021 Johnson & Johnson Consumer Inc.

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