Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID bd85a219-3d3e-423e-bec9-ea25f79a0787
Route
ORAL
Published
Effective Date 2018-06-08
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 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-06-07
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

helps reduce plaque that leads to

  • gingivitis
  • bleeding gums
Warnings

Stop use and ask a dentist if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Directions
  • Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your eth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
  • children 6 years to under 12 years of age: supervise use
  • children under 6 years of age: do not use
Label Copy

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.
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, Green 3 (CI 42053).

Questions Or Comments?

1-866-695-3030

Keep Out of Reach of Children Under 6 Years of Age.

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

Structured Label Content

Uses

helps reduce plaque that leads to

  • gingivitis
  • bleeding gums
Purpose

Antiplaque/Antigingivitis

Warnings

Stop use and ask a dentist if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Directions
  • Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your eth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
  • children 6 years to under 12 years of age: supervise use
  • children under 6 years of age: do not use
Label Copy (Label copy)

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.
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, Green 3 (CI 42053).

Questions Or Comments? (Questions or comments?)

1-866-695-3030

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:34.884729 · Updated: 2026-03-14T22:55:08.159087