Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 2673fffe-ba4d-427f-be0f-2127f6dbcb8c

Route

ORAL

Published

Effective Date 2014-02-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2014-02-13

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

Other Information

STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED

Active Ingredients

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

Inactive Ingredients

WATER (AQUA), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, GREEN 3 (CI 42053)

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)

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED

Active Ingredients (ACTIVE INGREDIENTS)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, GREEN 3 (CI 42053)

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

[{"name": "EUCALYPTOL", "unii": "RV6J6604TK", "classCode": "ACTIB", "strengthNumerator": "0.92", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "0.42", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "0.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "THYMOL", "unii": "3J50XA376E", "classCode": "ACTIB", "strengthNumerator": "0.64", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C GREEN NO. 3", "unii": "3P3ONR6O1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "TO HELP REDUCE AND PREVENT PLAQUE AND GINGIVITIS", "PURPOSE": "ANTIPLAQUE/ANTIGINGIVITIS", "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", "OTHER INFORMATION": "STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED", "ACTIVE INGREDIENTS": "EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%", "INACTIVE INGREDIENTS": "WATER (AQUA), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, GREEN 3 (CI 42053)", "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)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:44.959712 · Updated: 2026-03-14T22:53:41.456865