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
Purpose

Antigingivitis/Antiplaque

Description

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

Medication Information

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
Uses

Helps reduce plaque that leads to

  • gingivitis
  • bleeding gums
Purpose

Antigingivitis/Antiplaque

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

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
Inactive Ingredients

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

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.

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 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
Uses

Helps reduce plaque that leads to

  • gingivitis
  • bleeding gums
Purpose

Antigingivitis/Antiplaque

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

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
Inactive Ingredients (Inactive ingredients)

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

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. (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