drug facts

drug facts
SPL v1
SPL
SPL Set ID 1724227f-fadd-4b31-831e-d4e7ccba7292
Route
oral
Published
Effective Date 2014-05-07
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 sorbitol poloxamer 407 benzoic acid saccharin sodium sodium benzoate fd&c green no. 3

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2014-05-06
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 SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, 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 (WARNINGS)

DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE

Uses (USES)

TO HELP REDUCE AND PREVENT PLAQUE AND GINGIVITIS

Purpose (PURPOSE)

ANTIPLAQUE/ANTIGINGIVITIS

Directions (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 SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, GREEN 3 (CI 42053)

Label Copy (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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:47.759272 · Updated: 2026-03-14T22:53:45.227062