Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 1bc78b29-cc1c-4a2e-9d5f-ad8395b399e4
Route
ORAL
Published
Effective Date 2016-03-03
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 Benzoic Acid Poloxamer 407 Sodium Benzoate Caramel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-02

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 reduce and prevent plaque and 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 Information
  • 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 (26.9%), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel.

Questions Or Comments?

1-800-289-8343

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 reduce and prevent plaque and 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 Information (Other information)
  • 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 (26.9%), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel.

Questions Or Comments? (Questions or comments?)

1-800-289-8343

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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