drug facts

drug facts
SPL v1
SPL
SPL Set ID 7979198e-af0d-4512-8818-a5613eb4454e
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 (0.60 1) thymol (0.64 1)
Inactive Ingredients
water alcohol poloxamer 407 benzoic acid sodium benzoate saccharin sodium sucralose fd&c green no. 3 d&c yellow no. 10

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, Poloxamer 407, Flavor, Benzoic Acid, Sodium Benzoate, Sodium Saccharin, Sucralose, 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%

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, Poloxamer 407, Flavor, Benzoic Acid, Sodium Benzoate, Sodium Saccharin, Sucralose, 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%

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: 2026-02-15T11:56:05.540577 · Updated: 2026-03-14T22:54:17.721451