drug facts

drug facts
SPL v1
SPL
SPL Set ID 0a2b97b8-6324-457c-a79d-6e7011bedddf
Route
oral
Published
Effective Date 2019-02-28
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 sodium benzoate saccharin sodium fd&c green no. 3 d&c yellow no. 10

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2019-02-27
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. Thes 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, Poloxamer 407, Flavor (Aroma), Benzoic Acid, Sodium Benzoate, Sodium Saccharin, Green 3 (CI 42053), Yellow 10 (CI 47005).

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%

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

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. Thes 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, Poloxamer 407, Flavor (Aroma), Benzoic Acid, Sodium Benzoate, Sodium Saccharin, Green 3 (CI 42053), Yellow 10 (CI 47005).

Label Copy

Active Ingredients (Active ingredients)

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

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: 2026-02-15T11:56:45.625286 · Updated: 2026-03-14T22:55:26.303656