listerine cool mint antiseptic

listerine cool mint antiseptic
SPL v11
SPL
SPL Set ID 9e97e4f8-80c2-44e0-862c-0dfca392a436
Route
oral
Published
Effective Date 2022-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
eucalyptol (0.92 mg) menthol, unspecified form (0.42 mg) salicylic acid (0.6 mg) thymol (0.64 mg)
Inactive Ingredients
water alcohol sorbitol poloxamer 407 benzoic acid saccharin sodium sodium benzoate fd&c green no. 3

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-12-03

Purpose

Antiplaque/antigingivitis

Description

Drug Facts


Medication Information

Warnings

Uses

Helps prevent and reduce:

  • Plaque
  • Gingivitis
Purpose

Antiplaque/antigingivitis

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
  • this rinse is not intended to replace brushing or flossing.
  • 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50569-3

Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use.

Section 50570-1

Do not use in children under 12 years of age

Purposes

Antiplaque/antigingivitis

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

Questions Or Comments?

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

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 ®

1.5L (1 Qt 1 Pt 2.7 fl oz)


Structured Label Content

Warnings

Uses

Helps prevent and reduce:

  • Plaque
  • Gingivitis
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 (Other information)
  • this rinse is not intended to replace brushing or flossing.
  • store at room temperature
  • cold weather may cloud this product. Its antiseptic properties are not affected.
Inactive Ingredients (Inactive ingredients)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50569-3 (50569-3)

Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use.

Section 50570-1 (50570-1)

Do not use in children under 12 years of age

Purposes

Antiplaque/antigingivitis

Active Ingredients (Active ingredients)

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

Questions Or Comments? (Questions or Comments?)

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

Principal Display Panel 1.5 L Bottle Label (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 ®

1.5L (1 Qt 1 Pt 2.7 fl oz)


Advanced Ingredient Data


Raw Label Data

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