Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b37ff2da-f771-48d0-b4cb-277bef22bc97
Route
ORAL
Published
Effective Date 2013-05-17
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 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-05-13
Description

EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%

Purpose

ANTIPLAQUE/ANTIGINGIVITIS

Medication Information

Purpose

ANTIPLAQUE/ANTIGINGIVITIS

Description

EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%

Uses

TO HELP REDUCE AND PREVENT PLAQUE AND GINGIVITIS.

Warnings

DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE.

Directions

RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML(2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT. DO NOT SWALLOW.

Label Copy

Active Ingredient

EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%

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 SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCARIN, SODIUM BENZOATE, GREEN 3 (CI 42053).

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

Uses (USES)

TO HELP REDUCE AND PREVENT PLAQUE AND GINGIVITIS.

Purpose (PURPOSE)

ANTIPLAQUE/ANTIGINGIVITIS

Warnings (WARNINGS)

DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE.

Directions (DIRECTIONS)

RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML(2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT. DO NOT SWALLOW.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%

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 SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCARIN, SODIUM BENZOATE, GREEN 3 (CI 42053).

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: 2026-02-15T11:55:37.850149 · Updated: 2026-03-14T22:53:29.712463