Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f285e738-7a4a-4355-b35e-706a30b001a8
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 D&c Yellow No. 10 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 FLUI DOUNCE 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. CLOUD 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, YELLOW 10 (CI 47005), 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 FLUI DOUNCE 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. CLOUD 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, YELLOW 10 (CI 47005), 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

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