Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID bc89c301-e7fa-42b0-bce8-07cae668e37f
Route
ORAL
Published
Effective Date 2015-09-14
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 2015-09-13

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, Flavor, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Green 3 (CI 42053)

Questions Or Comments?

1-248-449-9300

Keep Out of Reach of Children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Structured Label Content

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
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, Flavor, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Green 3 (CI 42053)

Questions Or Comments? (Questions or comments?)

1-248-449-9300

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 (1-800-222-1222) immediately.


Advanced Ingredient Data


Raw Label Data

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