Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ffb10843-e1f5-4efd-a88f-5e1378591d15
Route
BUCCAL
Published
Effective Date 2016-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.92 mg) Menthol (0.42 mg) Salicylic Acid (0.60 mg) Thymol (0.64 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Benzoic Acid Saccharin Sodium Sodium Benzoate D&c Yellow No. 10 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-06-13

Description

Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Purpose

Antiplaque/Antigingivitis


Medication Information

Purpose

Antiplaque/Antigingivitis

Description

Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Uses

to help redce and prevent

  • plaque
  • gingivitis
Warnings

Do not use in children under 12 years of age.

Directions
  • rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night.
  • do not swallow.
Label Copy

Other Informaton
  • store at room temperature.
  • cold weather may cloud this product. Its antiseptic properties are not affected.
Active Ingredients

Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Inactive Ingredients

Water (Aqua), Alcohol (21.6%), Sorbitol, Flavor, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Yellow 10 (CI 47005), Green 3 (CI 42053).

Questions Or Comments?

1-866-695-3030

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

to help redce and prevent

  • plaque
  • gingivitis
Purpose

Antiplaque/Antigingivitis

Warnings

Do not use in children under 12 years of age.

Directions
  • rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night.
  • do not swallow.
Label Copy

Other Informaton (Other informaton)
  • store at room temperature.
  • cold weather may cloud this product. Its antiseptic properties are not affected.
Active Ingredients (Active ingredients)

Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Alcohol (21.6%), Sorbitol, Flavor, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Yellow 10 (CI 47005), Green 3 (CI 42053).

Questions Or Comments? (Questions or comments?)

1-866-695-3030

Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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