Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 24ad0af2-8694-4bf1-8cfd-0b43ba4514b5
Route
ORAL
Published
Effective Date 2018-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.92 mg) Menthol (0.42 mg) Salicylic Acid (0.6 mg) Thymol (0.64 mg)
Inactive Ingredients
Water Alcohol Poloxamer 407 Benzoic Acid Saccharin Sodium Sodium Benzoate Sucralose Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-02-14
Description

Eucalyptol 0.92%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

Medication Information

Purpose

Antigingivitis, Antiplaque

Description

Eucalyptol 0.92%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Uses

helps control plaque that leads to gingivitis, an early form of gum disease.

Warnings

Directions

Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow

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 0.92%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Inactive Ingredients

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

Questions Or Comments?

1-800-632-6900

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, increasing space between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Keep Out of Reach of Children Under 6 Years of Age.

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

Structured Label Content

Uses

helps control plaque that leads to gingivitis, an early form of gum disease.

Purpose

Antigingivitis, Antiplaque

Warnings

Directions

Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow

Children 6 years to under 12 years of age: supervise use.

Children under 6 years of age: do not use

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 0.92%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-632-6900

Stop Use and Ask A Dentist If (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, increasing space between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
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 ingested, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:31.450168 · Updated: 2026-03-14T22:55:01.972489