Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b9fb77bb-5c11-4cab-93a8-fdfb8696a45b
Route
ORAL
Published
Effective Date 2019-01-08
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 Benzoic Acid Fd&c Green No. 3 Poloxamer 407 Sodium Benzoate Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-01-07
Description

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

Purpose

Antigingivitis/Antiplaque

Medication Information

Purpose

Antigingivitis/Antiplaque

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 see your dentist immediately 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 space between the teeth. These may be signs or symptoms or periodontitis, a serious form of gum disease
Directions
  • Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse.
  • Children 6 to 12 years of age: supervise use
  • Children under 6 years of age: do not use

Label Copy

Other Information
  • not intended to replace brushing or flossing
  • store at room temperature (59°F - 77°F)
  • cold weather may cloud this product, but will not affect its antiseptic properties
Active Ingredients

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

Inactive Ingredients

alcohol (21.6%), benzoic acid, flavor, green 3, poloxamer 407, sodium benzoate, sodium saccharin, sorbitol, water.

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

Helps reduce plaque that leads to

  • gingivitis
  • bleeding gums
Purpose

Antigingivitis/Antiplaque

Warnings

Stop use and see your dentist immediately 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 space between the teeth. These may be signs or symptoms or periodontitis, a serious form of gum disease
Directions
  • Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse.
  • Children 6 to 12 years of age: supervise use
  • Children under 6 years of age: do not use

Label Copy

Other Information (Other information)
  • not intended to replace brushing or flossing
  • store at room temperature (59°F - 77°F)
  • cold weather may cloud this product, but will not affect its antiseptic properties
Active Ingredients (Active ingredients)

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

Inactive Ingredients (Inactive ingredients)

alcohol (21.6%), benzoic acid, flavor, green 3, poloxamer 407, sodium benzoate, sodium saccharin, sorbitol, water.

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:44.067566 · Updated: 2026-03-14T22:55:24.290889