drug facts

drug facts
SPL v2
SPL
SPL Set ID a6ee1801-7535-4b20-b9f9-ebcf734c7602
Route
oral
Published
Effective Date 2016-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
eucalyptol (0.92 mg) menthol (0.42 mg) salicylic acid (0.06 mg) thymol (0.064 mg)
Inactive Ingredients
water alcohol sorbitol poloxamer 407 benzoic acid zinc chloride sucralose sodium benzoate fd&c yellow no. 6 fd&c red no. 40

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-02-10
Purpose

Antiplaque/Antigingivitis

Description

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

Medication Information

Warnings

Do not use for children under 12 years of age.

Uses

To help reduce and prevent plaque and gingivitis.

Purpose

Antiplaque/Antigingivitis

Directions
  • Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night.
  • Do not swallow.
Other Information
  • 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, Benzoic Acid, Sodium Benzoate, Zinc Chloride, Sucralose, Yellow 6 (CI 15985), Red 40 (CI 16035).

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?

1-800-842-7886

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 (1-800-222-1222).

Structured Label Content

Warnings

Do not use for children under 12 years of age.

Uses

To help reduce and prevent plaque and gingivitis.

Purpose

Antiplaque/Antigingivitis

Directions
  • Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night.
  • Do not swallow.
Other Information (Other information)
  • 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, Benzoic Acid, Sodium Benzoate, Zinc Chloride, Sucralose, Yellow 6 (CI 15985), Red 40 (CI 16035).

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?)

1-800-842-7886

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 (1-800-222-1222).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:04.312080 · Updated: 2026-03-14T22:54:15.762833