drug facts

drug facts
SPL v2
SPL
SPL Set ID 6a7eee5d-182d-49bb-9be0-a32776b83736
Route
oral
Published
Effective Date 2016-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
eucalyptol (0.92 mg) menthol (0.42 mg) salicylic acid (0.6 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 2016-03-08
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, 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?

1-800-842-7886

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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

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 (1-800-222-1222) immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:05.609741 · Updated: 2026-03-14T22:54:18.927073