Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 44d77541-d6e2-4bd8-997d-53913bff975f

Route

ORAL

Published

Effective Date 2013-09-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

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 Benzoic Acid Poloxamer 407 Sodium Benzoate Caramel

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-09-12

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 (26.9%), BENZOIC ACID, POLOXAMER 407, SODIUM BENZOATE, CARAMEL.

Questions Or Comments?

1-800-289-8343

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.

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 (26.9%), BENZOIC ACID, POLOXAMER 407, SODIUM BENZOATE, CARAMEL.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-289-8343

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.

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": "0.60", "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": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARAMEL", "unii": "T9D99G2B1R", "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 (26.9%), BENZOIC ACID, POLOXAMER 407, SODIUM BENZOATE, CARAMEL.", "QUESTIONS OR COMMENTS?": "1-800-289-8343", "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."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:41.643340 · Updated: 2026-03-14T22:53:35.209708