drug facts

drug facts
SPL v1
SPL
SPL Set ID 9888b330-9638-4a74-8f50-ee482c63eb07
Route
oral
Published
Effective Date 2015-04-09
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 d&c yellow no. 10

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2015-04-08

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
  • 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, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, YELLOW 10 (CI 47005), 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%

Questions Or Comment?

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

Warnings (WARNINGS)

DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE

Uses (USES)

TO HELP REDUCE AND PREVENT

  • PLAQUE
  • 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, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, YELLOW 10 (CI 47005), 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%

Questions Or Comment? (QUESTIONS OR COMMENT?)

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


Raw Label Data

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