drug facts

drug facts
SPL v1
SPL
SPL Set ID e0d723d7-7de5-4ff0-97a7-90560dc28015
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 d&c yellow no. 10 fd&c green no. 3

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2018-06-07
Purpose

Antiplaque/Antigingivitis

Description

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

Medication Information

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.
Uses

helps reduce plaque that leads to

  • gingivitis
  • bleeding gums
Purpose

Antiplaque/Antigingivitis

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 the rinse.
  • children 6 years to under 12 years of age: supervise use.
  • children under 6 years of age: do not use.
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 (Aqua), Alcohol (21.6%), Sorbitol, Flavor, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Yellow 10 (CI 47005), Green 3 (CI 42053).

Description

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

Label Copy

Active Ingredients

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

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 Poison Control Center immediately.

Structured Label Content

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.
Uses

helps reduce plaque that leads to

  • gingivitis
  • bleeding gums
Purpose

Antiplaque/Antigingivitis

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 the rinse.
  • children 6 years to under 12 years of age: supervise use.
  • children under 6 years of age: do not use.
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 (Aqua), Alcohol (21.6%), Sorbitol, Flavor, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Yellow 10 (CI 47005), Green 3 (CI 42053).

Label Copy (Label copy)

Active Ingredients (Active ingredients)

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

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 Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:34.885882 · Updated: 2026-03-14T22:55:08.159087